Displaying publications 61 - 80 of 133 in total

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  1. Rafiq MT, Hamid MSA, Hafiz E
    ScientificWorldJournal, 2021;2021:6672274.
    PMID: 34975349 DOI: 10.1155/2021/6672274
    BACKGROUND: Osteoarthritis (OA) of the knee is defined as a progressive disease of the synovial joints and is characterized by wear and tear of the cartilage and underlying bone. This study aimed to determine the short-term effects of the lower limb rehabilitation protocol (LLRP) on pain, stiffness, physical function, and body mass index (BMI) among knee OA participants who were overweight or obese. Methodology. A single-blinded randomized controlled trial of one-month duration was conducted at Rehmatul-Lil-Alameen Postgraduate Institute, Lahore, Pakistan. Fifty overweight or obese participants with knee OA were randomly divided into two groups by a computer-generated number. Participants in the rehabilitation protocol group (RPG) were provided with leaflets explaining the strengthening exercises of the LLRP and instruction of daily care (IDC), while the participants in the control group (CG) were provided with leaflets explaining the IDC only for a duration of four weeks. The primary outcome measures were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for pain, stiffness, and physical function. The secondary outcome measures were BMI, exercise adherence, and patients' satisfaction assessed by using the numeric rating scale ranging from 0 to 10. The paired-sample t-test was used to analyze the differences within groups from baseline to posttest evaluations. The analysis of variance 2 × 2 factor was used to analyze the differences in BMI, knee pain, stiffness, and physical function between the groups.

    RESULTS: Participants in the RPG and CG reported a statistically significant reduction in knee pain and stiffness (p ≤ 0.05) within the group. The reduction in the scores of knee pain was higher in participants in the RPG than that in participants in the CG (p=0.001). Additionally, participants in the RPG reported greater satisfaction (p=0.001) and higher self-reported exercise adherence (p=0.010) and coordinator-reported exercise adherence (p=0.046) than the participants in the CG.

    CONCLUSION: Short-term effects of the LLRP appear to reduce knee pain and stiffness only, but not physical function and BMI.

    Matched MeSH terms: Single-Blind Method
  2. Battal Merlet L, Morel S, Blanchet A, Lockman H, Kostova M
    Psychiatry Res, 2014 Dec 30;220(3):752-9.
    PMID: 25240943 DOI: 10.1016/j.psychres.2014.08.034
    Schizophrenia is associated with severe episodic retrieval impairment. The aim of this study was to investigate the possibility that schizophrenia patients could improve their familiarity and/or recollection processes by manipulating the semantic coherence of to-be-learned stimuli and using deep encoding. Twelve schizophrenia patients and 12 healthy controls of comparable age, gender, and educational level undertook an associative recognition memory task. The stimuli consisted of pairs of words that were either related or unrelated to a given semantic category. The process dissociation procedure was used to calculate the estimates of familiarity and recollection processes. Both groups showed enhanced memory performances for semantically related words. However, in healthy controls, semantic relatedness led to enhanced recollection, while in schizophrenia patients, it induced enhanced familiarity. The familiarity estimates for related words were comparable in both groups, indicating that familiarity could be used as a compensatory mechanism in schizophrenia patients.
    Matched MeSH terms: Single-Blind Method
  3. Wong SS, Nathan AM, de Bruyne J, Zaki R, Mohd Tahir SZ
    Indian J Pediatr, 2013 Jul;80(7):590-5.
    PMID: 22798280 DOI: 10.1007/s12098-012-0839-0
    The aim of this study was to evaluate the impact of a written asthma action plan (WAAP) on reducing unscheduled doctor visits, asthma control and quality of life in children with all severities of asthma. This was a randomised controlled, single-blinded study whereby 80 children with asthma were randomly assigned to be either provided a WAAP or verbally counseled . The number of asthmatic exacerbations requiring unscheduled doctor visits, asthma control and quality of life were monitored over 9 mo. At the end of the study, there was no significant difference in the number of unscheduled doctor visits between the 2 groups (p = 0.352). There was no significant difference in asthma control or quality of life between both groups. Hence, the WAAP did not reduce unscheduled doctor visits, nor improve asthma control or quality of life in children with all severities of asthma.
    Matched MeSH terms: Single-Blind Method
  4. Esa K, Azarinah I, Muhammad M, Helmi MA, Jaafar MZ
    Med J Malaysia, 2011 Aug;66(3):182-6.
    PMID: 22111436
    This was a prospective randomized study comparing the ease of insertion, haemodynamic changes, quality of airway seal, oxygenation and ventilation parameters and complications between Laryngeal Tube Suction II (LTS II) with Proseal Laryngeal Mask Airway (PLMA), both are supraglottic airway incorporated with gastric passage. Fifty-four ASA I and II patients were randomly allocated to receive either LTS II or PLMA. Both devices provided a secure airway even under conditions of elevated intra-abdominal pressure up to 17 mmHg. In this study, there were no differences concerning ease of insertion, haemodynamic changes, quality of airway seal, oxygenation and ventilation parameters and complications between LTS II and PLMA.
    Matched MeSH terms: Single-Blind Method
  5. Noor Zairul M, Khairul Faizi A, Norzalina E
    Med J Malaysia, 2006 Jun;61(2):157-61.
    PMID: 16898305
    The purpose of this study is to assess whether the newly developed laryngeal tube (LT) VBM is easy, simple to use and able to provide adequate ventilation and oxygenation to a patient with an unstable neck who required airway management. We compared the LT to the laryngeal mask airway (LMA) as alternative airway management tool in adult patient with unstable neck who underwent intubation with manual in-line neck stabilization. A randomized single-blinded prospective study was conducted involving a total of 40 ASA I and II premedicated patients who were divided into two groups with 20 patients for each group; either LT or LMA group for airway management during elective surgery. After preoxygenation, anaesthesia was induced and neuromuscular blockade was produced with intravenous drugs. The LT or LMA was inserted after neuromuscular blockade was confirmed using a peripheral nerve stimulator (TOF 1). A size 3, 4 or 5 LT OR a size 3 or 4 LMA was inserted while the patient's head and neck were being stabilized by an assistant who held the sides of the neck and the mastoid processes (manual in-line stabilization). If it was not possible to ventilate the lungs, or if endotrachial carbon dioxide (ETCO2) and/or chest movement did not indicate a patent airway, the LT or LMA was removed. After three failed attempts, the study was terminated and the airway was secured in the most suitable manner determined by the anaesthetist. There was a statistically significant difference for both groups in the time required for successful insertion (time required for LT was 24.8 +/- 7.7 seconds and LMA was 36.1+/-17.3 seconds) (p= 0.01). There was no statistical differences (p>0.05) in number of attempts needed to achieve a patent airway although we were able to achieve a clear airway in all patients in LT group at the first attempt compared with 85% in LMA group. successful insertion rate was 100% for both groups. We conclude that the LT is easier to insert and is a suitable alternative to the LMA for airway management when the patient's head and neck are stabilized by manual in-line method.
    Matched MeSH terms: Single-Blind Method
  6. Sukcharanjit S, Tan AS, Loo AV, Chan XL, Wang CY
    Anaesthesia, 2015 Dec;70(12):1390-4.
    PMID: 26348782 DOI: 10.1111/anae.13212
    Surgical drapes used during eye surgery are impermeable to air and hence risk trapping air underneath them. We investigated the effect of a forced-air warming blanket on carbon dioxide accumulation under the drapes in patients undergoing eye surgery under local anaesthesia without sedation. Forty patients of ASA physical status 1 and 2 were randomly assigned to either the forced-air warmer (n = 20) or a control heated overblanket (n = 20). All patients were given 1 l.min(-1) oxygen. We measured transcutaneous and end-tidal carbon dioxide partial pressures, heart rate, arterial pressure, respiratory rate, temperature and oxygen saturation before and after draping, then every 5 min thereafter for 30 min. The mean (SD) transcutaneous carbon dioxide partial pressure in the forced-air warming group stayed constant after draping at 5.7 (0.2) kPa but rose to a maximum of 6.4 (0.4) kPa in the heated overblanket group (p = 0.0001 for the difference at time points 15 min and later). We conclude that forced-air warming reduces carbon dioxide accumulation under the drapes in patients undergoing eye surgery under local anaesthesia.
    Matched MeSH terms: Single-Blind Method
  7. Loh DA, Hairi NN, Choo WY, Mohd Hairi F, Peramalah D, Kandiben S, et al.
    BMC Geriatr, 2015;15:8.
    PMID: 25887235 DOI: 10.1186/s12877-015-0002-7
    The ability of older people to function independently is crucial as physical disability and functional limitation have profound impacts on health. Interventions that either delay the onset of frailty or attenuate its severity potentially have cascading benefits for older people, their families and society. This study aims to develop and evaluate the effectiveness of a multiComponent Exercise and theRApeutic lifeStyle (CERgAS) intervention program targeted at improving physical performance and maintaining independent living as compared to general health education among older people in an urban poor setting in Malaysia.
    Matched MeSH terms: Single-Blind Method
  8. Wang CY, Ling LC, Cardosa MS, Wong AK, Wong NW
    Anaesthesia, 2000 Jul;55(7):654-8.
    PMID: 10919420
    In Study A, the incidence of arterial oxygen desaturation was studied using pulse oximetry (SaO2) in 100 sedated and 100 nonsedated patients breathing room air who underwent diagnostic upper gastrointestinal endoscopy. Hypoxia (SaO2 92% or less of at least 15 s duration) occurred in 17% and 6% of sedated patients and nonsedated patients, respectively (p < 0.03). Mild desaturation (SaO2 94% or less and less than 15 s duration) occurred in 47% of sedated patients compared with 12% of nonsedated patients (p < 0.001). In Study B, the effects of supplementary oxygen therapy and the effects of different pre-oxygenation times on arterial oxygen saturation (SaO2) in sedated patients were studied using pulse oximetry. One hundred and twenty patients who underwent diagnostic upper gastrointestinal endoscopy with intravenous sedation were studied. Patients were randomly allocated to one of four groups: Group A (n = 30) received no supplementary oxygen while Groups B-D received supplementary oxygen at 4 1 x min(-1) via nasal cannulae. The pre-oxygenation time in Group B (n = 30) was zero minutes, Group C (n = 30) was 2 min and Group D (n = 30) was 5 min before sedation and introduction of the endoscope. Hypoxia occurred in seven of the 30 patients in Group A and none in groups B, C and D (p < 0.001). We conclude that desaturation and hypoxia is common in patients undergoing upper gastrointestinal endoscopy with and without sedation. Sedation significantly increases the incidence of desaturation and hypoxia. Supplementary nasal oxygen at 4 1 x min(-1) in sedated patients abolishes desaturation and hypoxia. Pre-oxygenation confers no additional benefit.
    Matched MeSH terms: Single-Blind Method
  9. Ho TM, Shara S, Koay AS, Cheong YM
    J Med Entomol, 1992 Jul;29(4):611-3.
    PMID: 1495069
    A dot-immunobinding assay (DIBA) was compared with a direct fluorescent antibody technique (DFAT) for the detection of Rickettsia tsutsugamushi infection in Leptotrombidium fletcheri (Womersley & Heaslip). Laboratory colonies of infected and noninfected chiggers were examined. The relative proportions of positive, negative, and indeterminate results were significantly different between DIBA and DFAT for infected but not for noninfected chiggers. DIBA was more sensitive and had a better negative predictive value and a lower false negative percentage than DFAT. It was concluded that DIBA is a suitable alternative to DFAT for detecting scrub typhus infection in chiggers.
    Matched MeSH terms: Single-Blind Method
  10. Rizal AM, Aljunid SM, Normalina M, Hanom AF, Chuah KL, Suzainah Y, et al.
    Med J Malaysia, 2003 Aug;58(3):380-6.
    PMID: 14750378
    A randomised single blinded clinical trial to compare the cost of cataract surgery between extracapsular cataract extraction (ECCE) and phacoemulsification (PEA) was conducted at Hospital Universiti Kebangsaan Malaysia (HUKM) between March and December 2000. A total of 60 patients were included in this study. The cost of a cataract surgery incurred by hospital, patients and households up to two months after discharge were included. The costs of training, loss of patients' income after discharge and intangible costs were excluded. Results showed that the average cost for one ECCE operation is RM1,664.46 (RM1,233.04-RM2,377.64) and for PEA is RM1,978.00 (RM1,557.87-RM3,334.50). During this short period of follow up, it can be concluded that ECCE is significantly cheaper than PEA by an average difference of RM 313.54 per patient (p < 0.001). Cost of equipment and low frequency of PEA technique done in HUKM were the two main reasons for the high unit cost of PEA as compared to ECCE.
    Matched MeSH terms: Single-Blind Method
  11. Mohammadzadeh M, Awang H, Ismail S, Shahr HK
    Asian J Psychiatr, 2020 Feb;48:101892.
    PMID: 31864126 DOI: 10.1016/j.ajp.2019.101892
    The current study amid to determine whether a life skills-based education could improve coping skills among adolescents in Malaysian orphanages. It was a randomized controlled trial comprising intervention and control groups which were randomly selected to receive the life skills, or the Placebo education programmes. The DASS21 and Brief COPE were used as the study instruments. Results showed the mean scores of self-distraction, active coping, use of emotional support, use of instrumental support, positive reinterpretation, planning and acceptance, at post-test, were significantly increased compared to the pre-test values. Denial, substance abuse, behavioural disengagement and self-blame significantly decreased. The findings provide an opportunity to assess the effects of participation in a life skills education programme on behavioural health in Malaysia orphanages.
    Matched MeSH terms: Single-Blind Method
  12. Pui Kei C, Mohd Nordin NA, Abdul Aziz AF
    Medicine (Baltimore), 2020 Nov 20;99(47):e23296.
    PMID: 33217861 DOI: 10.1097/MD.0000000000023296
    INTRODUCTION: Stroke survivors are commonly at risk of functional decline following discharge from rehabilitation, which increase their susceptibility to falls, dependency in activities of daily living and emotional disturbances. To combat these, continued therapy is important. Home-based therapy (HBT) has been shown to be useful in maintaining functional performance and quality of life of chronic stroke survivors. However, evidence on its effectiveness remains limited, while no studies are available to date which report the benefit of HBT on stroke survivors self-efficacy and emotional status. Therefore, this study aims to assess the effectiveness of post-discharge HBT in comparison to usual practice on functional outcome (mobility and gait speed), self-efficacy and anxiety level among stroke survivors.

    METHODS: This is an assessor-blinded randomized control trial comparing 2 types of intervention which are HBT (experimental group) and usual practice (UP) (control group). Based on sample size calculation using GPower, a total number of 42 participants will be recruited and allocated into either the HBT or the UP group. Participants in HBT group will receive a set of structured exercise therapy consisting of progressive strengthening, balance and task-related exercises. While participants in UP group will receive a usual "intervention" practised by rehabilitation professional prior to discharging stroke patients from their care. Both groups are advised to perform the given interventions for 3 times per week for 12 weeks under the supervision of their caregiver. Outcomes of interventions will be measured using timed up and go test (for mobility), ten-meter walk test (for gait speed), stroke self-efficacy questionnaire (for self-efficacy) and hospital anxiety and depression scale (for anxiety level). All data will be analyzed using descriptive and inferential statistics.

    DISCUSSION: This study will provide the information on the effectiveness of HBT in comparison to UP among stroke population who are discharged from rehabilitation. Findings from the study will enable rehabilitation professionals to design effective discharge care plan for stroke survivors in combating functional decline when no longer receiving hospital-based therapy.

    TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619001182189 (last updated 22/11/2019).

    Matched MeSH terms: Single-Blind Method
  13. Ng AWR, Loh KK, Gupta N, Narayanan K
    Clin Nutr ESPEN, 2019 10;33:39-41.
    PMID: 31451273 DOI: 10.1016/j.clnesp.2019.07.014
    BACKGROUND & AIMS: Consumption of sugars in food and beverages has increased at an alarming rate. While excessive daily sugar intake has been well-associated as the onset of medical complications, additional sugars are still used in manufactured food products just to satisfy the consumers' needs. Hence, there is a need to develop sugar replacers that have low glycemic response without compromising the organoleptic characteristics of food products. This study aimed to determine if SUITENA™, a novel sweetener containing erythritol, xylitol, and Stevia, has low glycemic response upon consumption by human subjects.

    METHODS: Six human subjects were randomly chosen and were healthy at the point of experimentation. Capillary blood was collected via finger-prick method to monitor the glycemic response of every individual for 90 min after ingestion of sugar solution.

    RESULTS: It was found that the mean area under the curve (AUC) of the dextrose standard was 11.8-fold higher (p 

    Matched MeSH terms: Single-Blind Method
  14. Naqvi AA, Hassali MA, Naqvi SBS, Aftab MT
    Trials, 2019 Aug 09;20(1):488.
    PMID: 31399128 DOI: 10.1186/s13063-019-3540-z
    BACKGROUND: The objective of this study is to evaluate the effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health-related quality of life (HRQoL) and direct cost of treatment. The study also documents patient satisfaction with pharmacist counselling as a quality control measure.

    METHODS/DESIGN: This is a randomized, single-blind, two-arm, controlled trial in patients with rheumatoid arthritis visiting outpatient rheumatology clinics in Karachi, Pakistan. We will enroll patients with established diagnosis of rheumatoid arthritis over 3 months. The patients would be randomized through a computer-generated list into the control group, i.e., usual care or into the intervention group, i.e., pharmaceutical care, in a ratio of 1:1, after providing signed written consent. The study will take place in two patient-visits over the course of 3 months. Patients in the intervention group would receive intervention from the pharmacist while those in the control group will receive usual care. Primary outcomes include change in mean score from baseline (week 0) and at follow up (week 12) in disease knowledge, adherence to medications and rehabilitation/physical therapy. The secondary outcomes include change in the mean direct cost of treatment, HRQoL and patient satisfaction with pharmacist counselling.

    DISCUSSION: This is a novel study that evaluates the role of the pharmacist in improving treatment outcomes in patients with rheumatoid arthritis. The results of this trial could set the foundation for future delivery of care for this patient population in Pakistan. The results of this trial would be published in a peer-reviewed journal.

    TRIAL REGISTRATION: ClinicalTrials.gov, NCT03827148 . Registered on February 2019.

    Matched MeSH terms: Single-Blind Method
  15. Muhammad Aidil ZA, Hayati K, Rosliza AM
    Med J Malaysia, 2019 02;74(1):62-66.
    PMID: 30846665
    INTRODUCTION: For the last 30 years, tobacco smoking has continued to be the leading cause of premature deaths in Malaysia. Majority of the smokers in Malaysia are at the precontemplation and contemplation stages. Therefore, for the purpose of increasing smoking cessation among this group, the strategies that motivate them to quit smoking have to be reviewed.

    OBJECTIVE: This study aims to evaluate the effectiveness of carbon monoxide measurement feedback and the standard brief motivation adopted to encourage the smoker to quit.

    METHODS: A single-blind, cluster randomised controlled trial was conducted at ten tertiary colleges in Selangor. The study recruited young adult smokers at the precontemplation and contemplation stages. The subjects in the control group received a standard brief motivational strategy. On the other hand, the intervention group received additional carbon monoxide measurement and a motivational feedback module. A follow up was conducted at the first, third and sixth month to measure changes in smoking cessation stage. Subsequently, the secondary outcomes of a mean number of cigarette consumption and quit smoking attempt were analysed. A total of 160 subjects were required to detect the expected difference of 17% in primary outcomes between the groups. This study utilised Generalised Estimating Equations (GEE) to handle the clustering effects.

    CONCLUSION: Biomedical risk assessment feedback mechanism by using carbon monoxide is a promising aid to motivate the smoker to quit. This mechanism is a relatively easy, quick and non-invasive technique. Thus, it can be utilised as a reinforcement relating to the harmful effect of smoking. Besides, it can also increase the smokers' selfefficacy and decisional balance to adopt behavioural changes.

    Matched MeSH terms: Single-Blind Method
  16. Mansor M, Shan Lee Z, San LP, Mei Ng M, Al-Abd N, Kassim M
    Turk J Phys Med Rehabil, 2021 Mar;67(1):62-68.
    PMID: 33948545 DOI: 10.5606/tftrd.2021.4672
    Objectives: This study aims to investigate the effectiveness of biofeedback electrostimulation therapy (BEST) in chronic neuropathic pain and to evaluate changes in perceived level of pain and level of blood cortisol before and after treatment.

    Patients and methods: This single-blind, prospective, randomized-controlled study included a total of 20 patients (8 males, 12 females; mean age: 53.5±13.8; range, 31 to 82 years) with chronic neuropathic pain between January 2014 and June 2014. The patients were randomized to BEST (n=10) or placebo (n=10) group. Pain was measured using the Visual Analog Scale, and serum cortisol levels were measured before and after treatment.

    Results: There was no significant difference in the baseline demographics, diagnosis, and treatment modalities between the groups. Approximately 50% patients in the treatment group reported that the treatment was effective, compared to 30% in the placebo group. Pain score reduction after treatment in the BEST group was significant (p<0.05), while it was not significant in the placebo group (p=0.4). Cortisol levels significantly reduced only in the BEST group after treatment (p=0.013).

    Conclusion: The BEST yields reduction in pain severity and cortisol levels. Based on these results, it seems to be effective in the treatment of chronic neuropathic pain after a single treatment and may be more effective for long-term management.

    Matched MeSH terms: Single-Blind Method
  17. Farah Izzati binti Farush Khan, Yasmin Ooi Beng Houi, Patricia Matanjun, Fredie Robinson
    MyJurnal
    Introduction: Coronary heart disease (CHD) has become the number one cause of death worldwide. Past studies have established the efficiency of prebiotics, probiotics, and their combination on lowering blood lipids. However, the mechanism(s) on the reduction of cholesterol involved is not fully understood due to limited in-vivo studies. Therefore, the reported hypocholesterolaemic potential of probiotics and prebiotics supplementations warrants fur-ther research. This study examined the effectiveness of the intervention products on improving lipid profiles, (to-tal cholesterol (TC), HDL-C, LDL-C, TG). Methods: A randomized, single blind intervention involving 8 weeks of treatment followed by 4 weeks of washout period was carried out on 29 volunteers with TC 5.2-6.0 mmol/L who were screened from 517 volunteers. Exclusion criteria included chronic diseases, immune-compromised diseases, consumption of cholesterol-lowering drugs, and pregnancy if female. Informed consent was obtained before com-mencement of the study. Participants were randomly assigned to receive 2g/d Lactobacillus Acidophilus NCFM pro-biotic powder, 10g/d inulin, 10g/d dietary fibre, control intervention of 20mg/d statin, or control intervention of diet counseling. Results: No significant (p>0.05) changes were observed in the fasting blood glucose, physical activities and total nutrient intake of all the groups. Inulin reduced LDL-C by 12.13%. Probiotic reduced TC by 6.98%. Dietary fibre reduced TC by 8.6%, and LDL-C by 16.08%. Conclusion: Although the results showed no significant changes, it may be clinically significant as the intervention products improve the lipid profiles. It was concluded that the im-provement in the lipid profiles may be attributable to the intervention products.
    Matched MeSH terms: Single-Blind Method
  18. Jaffar A, Mohd Sidik S, Foo CN, Muhammad NA, Abdul Manaf R, Fadhilah Ismail SI, et al.
    PMID: 33946203 DOI: 10.3390/ijerph18094792
    BACKGROUND: The delivery of pelvic floor muscle training (PFMT) through mHealth apps has been shown to produce promising results in improving pelvic floor muscle strength and urinary incontinence (UI). However, there is limited evidence on mHealth apps designed for pregnant women who are at high risk of developing UI. This pilot study aims to evaluate the feasibility of conducting an effectiveness trial for a newly developed PFMT app among pregnant women in Malaysia.

    METHODS: This is a prospective, single-centre, single-blind, randomised controlled pilot feasibility study: The Kegel Exercise Pregnancy Training app (KEPT-app) Trial. Sixty-four incontinent pregnant women who attended one primary care clinic for the antenatal follow-up will be recruited and randomly assigned to either intervention or waitlist control group. The intervention group will receive the intervention, the KEPT-app developed from the Capability, Opportunity, Motivation-Behaviour (COM-B) theory with Persuasive Technology and Technology Acceptance Model.

    DISCUSSION: This study will provide a fine-tuning for our future randomised control study on the recruitment feasibility methods, acceptability, feasibility, and usability of the KEPT-app, and the methods to reduce the retention rates among pregnant women with UI.

    TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov on 19 February 2021 (NCT04762433) and is not yet recruiting.

    Matched MeSH terms: Single-Blind Method
  19. Sidik SM, Jaffar A, Foo CN, Muhammad NA, Abdul Manaf R, Ismail SIF, et al.
    BMJ Open, 2021 01 12;11(1):e039076.
    PMID: 33436465 DOI: 10.1136/bmjopen-2020-039076
    INTRODUCTION: Pelvic floor muscle training (PFMT) strongly recommended to incontinent pregnant women. The Kegel Exercise Pregnancy Training-app trial is a multicentre cluster-randomised study aims to assess the effectiveness and its cost-effectiveness of the mobile app guidance in PFMT among incontinent pregnant women.

    METHODS AND ANALYSIS: 370 pregnant women (aged 18 years old and above) will be recruited with International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form. Ten clusters (primary care clinics) will be randomly assigned to either PFMT or usual care in a 1:1 ratio by an independent researcher (sealed envelope). The primary outcome will be urinary incontinence, and the secondary outcomes (quality of life; PFMT adherence, psychological status and mobile apps' usability) will be assessed at four measurement time points (t0: baseline) and postintervention (t1: 4 weeks, t2: 8 weeks and t3: 8 weeks postnatal). T-test analysis will determine any significant differences at the baseline between the control and intervention groups. The mixed-model analysis will determine the effectiveness of the intervention at the population-average level for both the primary and secondary outcomes. For the cost-effectiveness analysis, expenditures during the study and 6 months after the intervention will be compared between the groups using the multiway sensitivity analysis. The recruitment planned will be in December 2020, and the planned end of the study will be in August 2021.

    ETHICS AND DISSEMINATION: This study protocol was approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia (JKEUPM-2019-368) and Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, NMRR-19-412-47116 (IIR) with the ANZCTR registration. This study will obtain informed written consent from all the study participants. The results which conform with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials will be published for dissemination in peer-reviewed journals and conference proceedings.

    TRIAL REGISTRATION NUMBER: ACTRN12619000379112.

    Matched MeSH terms: Single-Blind Method
  20. Sharifah WW, Nur HH, Ruzita AT, Roslee R, Reilly JJ
    Malays J Nutr, 2011 Aug;17(2):229-36.
    PMID: 22303576 MyJurnal
    INTRODUCTION: The present study describes a randomised controlled trial (RCT) based on a novel, generalisable intervention for childhood obesity, comparing the intervention with a no-treatment control group.
    METHOD: The Malaysian Childhood Obesity Treatment Trial (MASCOT) was a single-blind RCT of a dietetic treatment for childhood obesity in children of primary school age (7 to 11 years old) in Kuala Lumpur, Malaysia. The MASCOT comprising eight sessions, of an 8-hour family-centred group treatment programme is described, based on behavioural change techniques. The study sample was characterised by BMI z-score, health related quality of life reported by participants and their parents (PedsQL questionnaire), objectively measured habitual physical activity and sedentary behaviour (Actigraph accelerometry)
    RESULTS: The MASCOT sample of 107 children was characterised by a low quality of life, mean total score on PedsQL 67.7 (4.5) as reported by the children, and 66.0 (16.4) as reported by their parents. The children spent, on average, 89% of their waking day on sedentary activity, and 1% of the day in moderate-vigorous intensity physical activity, equivalent to only around 8 minutes/day.
    CONCLUSION: Obese children in the MASCOT study had an impaired quality of life, high levels of sedentary behaviour and very low levels of physical activity.
    Matched MeSH terms: Single-Blind Method
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