SMS Reminders for Exercise Among Older Adults. Malaysian Physical Activity for Health Study (myPAtHS)

May 25, 2015 updated by: University of Malaya

Promoting Exercise Among Older Malaysians Using SMS Reminders. The Malaysian Physical Activity for Health Study (myPAtHS): A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Petaling Jaya, Selangor, Malaysia
        • Premises of research participants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Exercise programme only
Participants randomized in this condition will not receive SMS reminders to execute the myPAtHS exercise programme.
Experimental: SMS reminder
Participants in this study arm will receive SMS reminders to motivate them to execute the myPAtHS exercise programme.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of myPAtHS exercise sessions.
Time Frame: 12 weeks & 24 weeks
This will be assessed with an exercise diary.
12 weeks & 24 weeks
Time spent doing the myPAtHS exercise programme.
Time Frame: 12 weeks & 24 weeks
This will be assessed with an exercise diary.
12 weeks & 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in overall physical activity.
Time Frame: baseline, 12 weeks & 24 weeks
The International Physical Activity Questionnaire (short version) will be used to collect physical activity data.
baseline, 12 weeks & 24 weeks
Change in exercise self-efficacy.
Time Frame: baseline, 12 weeks & 24 weeks
The Exercise Self-Efficacy-Scale will be used to collect exercise self-efficacy data.
baseline, 12 weeks & 24 weeks
Change in grip strength.
Time Frame: baseline, 12 weeks & 24 weeks
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
Change in leg-strength.
Time Frame: baseline, 12 weeks & 24 weeks
Leg-strength will be collected using the 30 seconds chair-stand-test.
baseline, 12 weeks & 24 weeks
Subjective intensity while doing the myPAtHS exercise programme.
Time Frame: 12 weeks & 24 weeks
This will be assessed with an exercise diary.
12 weeks & 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ANDRE M MüLLER, MA, University of Malaya
  • Study Chair: SELINA KHOO, PhD, University of Malaya
  • Study Chair: TONY MORRIS, PhD, Victoria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UM.C/625/1/HIR/MOHE/ASH/02-PA

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