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Promoting physical activity in older Malays with diabetes
ISRCTN ISRCTN71447000
DOI 10.1186/ISRCTN71447000
ClinicalTrials.gov identifier
EudraCT number
Public title Promoting physical activity in older Malays with diabetes
Scientific title Promoting physical activity in sedentary older Malays with type 2 diabetes: a randomized controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis 1. The groups receiving personalized feedback on physical activity patterns will demonstrate greater step counts, and improvements in clinical parameters and health status than the control group.
2. The groups receiving personalized feedback on physical activity patterns combined with peer supoort will demonstrate greater step counts, and improvements in clinical parameters and health status than the groups receiving personalized feedback only and the control group.
Lay summary Lay summary under review 1
Ethics approval 1. Monash University Human Research Ethics Committee, 15 August 2011, ref: CF11/1018-2011000524
2. The Malaysian Ministry of Health Medical Research Ethics Committee, 28 February 2011, ref: NMRR-10-1107-7328
Study design Three arm parallel randomized controlled trial
Countries of recruitment Malaysia
Disease/condition/study domain Type 2 diabetes
Participants - inclusion criteria 1. Malays aged 60 years and above
2. Diagnosed with type 2 diabetes mellitus (T2DM) at least for 1 year
3. Participating in regular follow up - at least 2 visits in the last 12 months
4. Sedentary lifestyle
5. No acute medical illness in the last 6 months
Participants - exclusion criteria 1. Had recent adjustment in the treatment regime needing increase dose of medication in the last two months
2. Presence of cognitive impairment Elderly Cognitive Assessment Questionnaire (ECAQ) < 7
3. Had uncontrolled hypertension (blood pressure ≥ 180/100 mmHg)
4. Presence of coronary artery syndrome
5. Presence of hemiparesis or hemiplegia
6. Has advanced osteoarthritis
7. Presence of psychiatric disorders (such as depression, anxiety, psychosis)
8. Has complications of diabetes such as proliferative retinopathy, renal impairment
9. Presence of uncontrolled respiratory conditions such as asthma or chronic obstructive pulmonary disease
10. Known hearing impairment
11. Known visual impairment (visual acuity worse than 6/12 after optical correction)
12. Lives in residential homes
Anticipated start date 09/04/2012
Anticipated end date 31/12/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 60
Interventions Eligible participants are allocated into three groups using a computed random numbers generator based on blocked randomisation.
1. Control group (receive usual diabetes care)
2. Personalized feedback on physical activity patterns: a structured written feedback on participantís physical activity patterns. The participantís activity patterns will be described based on the calculation of minutes spent walking in a week (obtained from the daily activity diary). The duration achieved will be plotted on a graph. This feedback will be provided as a printed material.
3. Personalized feedback on physical activity patterns combined with peer support: Participants in this group will receive an intervention delivered by peer mentors. The peer mentors will provide the structured written feedback on the physical activity patterns. The aim of the peer mentors is to motivate the participants to participate in physical activity and adhere to the activity. A peer mentor is an individual with T2DM for more than 5 years, engaged in regular physical activity, has HbA1c < 8% and live in the community of the study location.
Primary outcome measure(s) Pedometer-determined step counts documented in an activity diary measured at enrollment, 12 weeks post intervention, 24 and 36 weeks follow-up.
Secondary outcome measure(s) 1. Glycosylated haemoglobin level (HbA1c)
2. Lipid profile
3. Blood pressure
4. Functional fitness (6 minute walk test)
5. Mobility (timed up and go test)
6. Body composition (Body mass index, waist circumference, body fat percentage)
6. General health status (health related quality of life and psychological wellbeing)
7. Perceived social support
8. Self-efficacy to exercise

Measured at enrollment, 12 weeks post intervention, 24 and 36 weeks follow-up
Sources of funding Monash University Sunway Campus (Malaysia) ref: M-GPH-MG-68
Trial website
Publications
Contact name Dr  Shariff-Ghazali  Sazlina
  Address Jeffrey Cheah School of Medicine
Monash University Sunway Campus
  City/town Bandar Sunway
  Zip/Postcode 46150
  Country Malaysia
Sponsor Monash University (Malaysia)
  Address Sunway Campus
Jalan Lagoon Selatan
Selangor Darul Ehsan
  City/town Bandar Sunway
  Zip/Postcode 46150
  Country Malaysia
  Sponsor website: http://www.monash.edu.my/
Date applied 05/04/2012
Last edited 04/05/2012
Date ISRCTN assigned 04/05/2012
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