Multi-modal Training Program to Promote Physical Activity After Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-90
SponsorSingapore General Hospital

About this trial

The goal of this study is to learn if a behavioral change intervention can improve physical activity in stroke survivors living in the community.

The main question it aims to answer is, if a behaviour change intervention and personalised physical activity prescription, are effective in improving the time spent in moderate to vigorous physical activity amongst chronic stroke survivors.

Researchers will compare the intervention group to a control group, to see if physical activity counselling and a personalized physical activity prescription is more effective in improving moderate to vigorous physical activity, than usual care alone. The study period for each participant is 6 months. Assessments are conducted at month 1 (baseline), 3 and 6.

The control group will receive only usual care, which consists of an information sheet on physical activity with the following content: (1) Why be active and (2) How to be active (with URL links to resources and videos). The usual care is delivered at 3-time points during month 1, 3 and 6.

The intervention group will receive usual care and a behavioral change intervention. The behavioral change intervention consists of up to 6 individual physical activity counselling sessions and a personalized physical activity prescription. The 6 sessions will take place only during months 1 to 3 and there will be no intervention during months 4 to 6. Of the 6 sessions, 3 are conducted face-to-face and another 3 sessions will take place using telehealth methods such as phone, text messaging and videoconference. Participants can meet the study physiotherapist at their preferred exercise space during the 3 face-to-face sessions. The physical activity counselling sessions consist of goal setting and action planning, and problem-solving barriers around participation in physical activity. The overall aim is to increase time spent in moderate-vigorous physical activity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 21 years and over

Haemorrhagic or ischaemic stroke

At least 6 months post-stroke

Living at home

Disqualifiers

Living in residential care

Unstable cardiac conditions, severe arthritis, or other conditions limiting the ability to exercise

Advised by GP/consultant not to undertake moderate-intensity exercise for health reason

Currently already participating in physical activity that meets recommended levels (150mins of moderate-vigorous physical activity)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention group

    Behavioral

    Please refer to arm descriptions

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of moderate to vigorous physical activity

Average minutes/day, measured by Fitbit Inspire 3 tracker

Time frame
Initial assessment (month 1), month 3 and 6 follow-up.

Secondary outcomes

1

Number of steps per day

Number of steps per day, measured by Fitbit Inspire 3 tracker

Time frame
Initial assessment (month 1), month 3 and 6 follow-up.
2

International Physical Activity Questionnaire Short Form (IPAQ-SF)

Duration (in minutes) and frequency (days) of walking, moderate-intensity, and vigorous-intensity activity, which are used to compute the total score.

Time frame
Initial assessment (month 1), month 3 and 6 follow-up.
3

Modified Rankin Scale

0\. No symptoms 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability: unable to carry out all previous activities but able to look after own affairs without assistance 3. Moderate disability: requiring some help, but able to walk without assistance 4. Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance 5. Severe disability: bedridden, incontinent, and requiring constant nursing care and attention Outcome data: One score from a 6-point scale of 0-5.

Time frame
Initial assessment (month 1), month 3 and 6 follow-up.
4

Functional Ambulation Category

0\) Patient cannot walk, or needs help from 2 or more persons 1. Patients needs firm continuous support from 1 person who helps carrying weight and with balance 2. Patient needs continuous or intermittent support of one person to help with balance and coordination 3. Patient requires verbal supervision or stand-by help from one person without physical contact 4. Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces 5. Patient can walk independently anywhere Outcome data: One score from a 6-point scale of 0-5

Time frame
Initial assessment (month 1), month 3 and 6 follow-up.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Singapore General Hospital

Lead sponsor

Singapore Institute of Technology

Collaborator

National Neuroscience Institute

Collaborator