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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02123342
Other study ID # UM.C/625/1/HIR/MOHE/ASH/02-PA
Secondary ID
Status Completed
Phase N/A
First received April 20, 2014
Last updated May 25, 2015
Start date June 2014
Est. completion date January 2015

Study information

Verified date May 2015
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority Malaysia: Medical Ethics Committee, University Malaya Medical Centre
Study type Interventional

Clinical Trial Summary

The purpose of the study is:

1) To evaluate the efficacy and feasibility of an SMS reminder intervention for promoting an health-related exercise programme (myPAtHS) among older Malaysian adults, in a randomized controlled trial (RCT).

Hypothesis: Frequency and duration of the exercise programme execution will be higher for the SMS reminder condition compared to the programme only condition. The effect may be reduced from post- to follow-up measurement (24 weeks after baseline and 12 weeks after post-measurement) but all outcomes will remain significantly higher at 24 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 55 Years to 70 Years
Eligibility Inclusion Criteria:

- Mobile phone user

- Acceptable health that does not prevent exercise

- Acceptable command of the English language

- No engagement in a regular- structured exercise routine like gym training or other structured programmes

- Interest in an exercise programme

- Willing to attend scheduled follow-up sessions at 12 weeks (pre-post evaluation) and 24 weeks (post-intervention evaluation) after the first session

Exclusion Criteria:

- participants who have any medical condition or health concern that would restrict regular exercise based on one screening question. If this question will be answered with "yes" participants are advised to seek medical care.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise programme plus SMS reminders
Participants will receive SMS reminders for their myPAtHS exercise programme compared to the other group where participants will only receive the myPAtHS exercise programme.

Locations

Country Name City State
Malaysia Premises of research participants Petaling Jaya Selangor

Sponsors (1)

Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of myPAtHS exercise sessions. This will be assessed with an exercise diary. 12 weeks & 24 weeks No
Primary Time spent doing the myPAtHS exercise programme. This will be assessed with an exercise diary. 12 weeks & 24 weeks No
Secondary Change in overall physical activity. The International Physical Activity Questionnaire (short version) will be used to collect physical activity data. baseline, 12 weeks & 24 weeks No
Secondary Change in exercise self-efficacy. The Exercise Self-Efficacy-Scale will be used to collect exercise self-efficacy data. baseline, 12 weeks & 24 weeks No
Secondary Change in grip strength. Grip strength will be assessed using the North Coast strength dynamometer (North Coast Hydraulic Hand Dynamometer, North Coast Medical Inc, Morgan Hill, California, USA). baseline, 12 weeks & 24 weeks No
Secondary Change in leg-strength. Leg-strength will be collected using the 30 seconds chair-stand-test. baseline, 12 weeks & 24 weeks No
Secondary Subjective intensity while doing the myPAtHS exercise programme. This will be assessed with an exercise diary. 12 weeks & 24 weeks No
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