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Spinal Cord InjuryNCT02833935

Enhancing Quality of Life Through Exercise: A Tele-Rehabilitation Approach

A study testing Physical Activity Intervention in people with Spinal Cord Injury, run by The Craig H. Neilsen Foundation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pilot randomized controlled trial evaluating a Self-Determination Theory (SDT) video-based tele-rehabilitation physical activity intervention aimed to enhance basic psychological needs, motivation, physical activity (PA), and quality of life- related outcomes of adults with spinal cord injury (SCI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injury
What is being tested?
Physical Activity Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
Aug 2016to Dec 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have spinal cord injury (paraplegia)
  • Must use a mobility device
  • Must have sustained their injury at least 1 year prior
  • Have a computer that matches requirements to use the online video-based software
  • Speak and understand English or French
  • Must have the intention to become physically active in the next two months or have been minimally active (< 2 times a week) in the past two months

Who cannot join

  • Receiving in-patient rehabilitation services
  • Have been diagnosed with memory impairments
  • Have severe communication difficulties and/or severe visual impairments
  • Do not require a mobility device (e.g., wheelchair, cane)
  • Have answered yes to one of the questions on the Physical Activity Readiness Questionnaire (PAR-Q+) and do not have a doctor's note saying it is safe for them to participate.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University; Dept. of Kinesiology & Physical Education; Theories and Interventions in Exercise and Health Psychology Laboratory

    Montreal, Quebec, H2V1S4

Other trials in Canada

About this study

Official title: Pilot Randomized Controlled Trial Evaluating a Self-Determination Theory Tele-rehabilitation Physical Activity Intervention to Enhance Motivation, Physical Activity, and Quality of Life-related Outcomes Among Adults With SCI

Pilot randomized controlled trial evaluating a Self-Determination Theory (SDT) video-based tele-rehabilitation physical activity intervention aimed to enhance basic psychological needs, motivation, physical activity (PA), and quality of life- related outcomes of adults with spinal cord injury (SCI). It is anticipated that the individuals who receive the physical activity intervention (intervention group) will have moderate increases in their basic psychological needs, autonomous motivation, life satisfaction, and physical activity participation, and a moderate decrease in controlled motivation and depressive symptoms compared to the individuals who did not receive the intervention (control group).

Read the detailed description

Adults with spinal cord injury (SCI) report lower levels of quality of life (e.g., low life satisfaction; high depression) than the general population and have low rates of community participation. One health behavior that can improve these psychosocial outcomes is physical activity (PA). Unfortunately, PA rates are very low among adults with SCI. Novel interventions to increase PA are needed. One approach that has gained traction is video-based tele-rehabilitation, which has the benefit of reducing costs, increasing accessibility to services and delivering and adapting the intervention to the person's home environment.

Experts have strongly recommended that PA interventions be based in psychological theory to enhance their effectiveness. The intervention will be grounded in a strong psychological/motivational theory called self-determination theory (SDT). According to SDT, humans strive for growth and well-being by aiming to satisfy their three basic psychological needs of autonomy (sense of volition), competence (sense of capability) and relatedness (sense of connectedness). The investigators intervention will therefore be designed to foster these psychological needs in order to increase intrinsic/autonomous motivation for PA, promote higher PA levels and improve quality of life and participation.

To date, no study has either conducted a video-based tele-rehabilitation intervention to promote PA or has tested SDT among adults with SCI; thus providing the need for a pilot intervention. The purpose of this study is to pilot test an innovative, theory-informed, video-based tele-rehabilitation intervention aimed to enhance SDT-variables, PA and quality of life-related variables among adults with SCI. Effect sizes derived from this pilot intervention will be used to inform the sample size calculation of a subsequent larger randomized controlled trial. Given previous video-based PA tele-rehabilitation interventions do not exist, the hypotheses are derived from PA and general telephone-based counselling studies. Specifically, it is hypothesized that the video-based intervention will have moderate effects on SDT variables, PA, participation, life satisfaction and depression.

Being tested
Physical Activity Intervention
Keywords
spinal cord injury, physical activity, self-determination theory, life satisfaction
Medical subject headings
Spinal Cord Injuries, Motor Activity, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity InterventionBehavioural

    The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential "Remote Education, Augmented Communication, Training and Supervision" online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants.

Study groups in NCT02833935
Study groupRoleWhat they receive
Physical Activity Intervention GroupExperimentalParticipants will complete a baseline questionnaire (week 1) about their demographic information, self-determination theory variables, their current physical activity, and other psychological indicators. They will complete the same questionnaire at two additional time points. First, about halfway through the intervention (week 6), and then at the end (week 10). Participants in the physical activity intervention group will also receive 8 1-hour physical activity sessions over 2 months (1/week) with a trained physical activity counselor through a video-based internet platform.
Receives: Behavioral: Physical Activity Intervention
Control GroupNo interventionControl Group: For participants assigned to the control group, they will be asked to continue with their regular routine for the next two months. Otherwise, the participants in this group will be asked to complete the follow-up baseline questionnaires at 6 and 10 weeks post-baseline. They will be contacted by a physical activity counsellor at the end of the 10-week period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Self-Regulation for Exercise Scale

    Measure to assess changes in autonomous and controlled types of motivation for reasons why one would exercise/engage in physical activity throughout the intervention. A total scale score range of 1 (not at all true) to 7 (very true) will be used to respond to 15 items. A mean score of participants' autonomous (6 items; " Because I personally believe it is the best thing for my health.") and controlled motivation (6 items; "Because I want others to approve of me.") will be calculated. A higher value indicates greater autonomous and or controlled types of motivation.

    Measured: Baseline, Week 6, and Week 10

  2. Psychological Needs for Exercise Questionnaire

    Measure to assess changes during the intervention in the basic psychological needs for exercise as per self-determination theory. Data will be collected at baseline, week 6, and week 10 for both participant groups. On a 6-point likert scale ranging from 1 (false) to 6 (true), participants will respond to 18 items reflecting how they might feel when physically active. After summating all items, a total mean score was calculated for autonomy (6 items; "I feel free to exercise in my own way"), competence (6 items; "I feel that I am able to complete exercises that are personally challenging"), and relatedness (6 items; "I feel close to my exercise companions who appreciate how difficult exercise can be"). A higher value indicates greater need satisfaction. Total values are reported in the data table as a sum of all 3 categories (Score range is 3-18).

    Measured: Baseline, Week 6, and Week 10

Secondary outcomes (5)

  1. Leisure Time Physical Activity Questionnaire for People With Spinal Cord Injury

    Questionnaire used to measure physical activity levels. Participants will be asked to indicate the frequency (days) and duration (in minutes) they engage in mild, moderate, and vigorous intensity activities over the last 7 days. Weekly minutes of total activity (mild, moderate, and vigorous) and of moderate and vigorous activity will be summed.

    Measured: Baseline, Week 6, and Week 10

  2. Person-Perceived Participation in Daily Activities Questionnaire

    Measure to assess participation in daily and social activities. Participants will be presented with a list of 26 activities. For each activity, they are asked, "Do you participate in this activity?" Response options are "Yes, as much as I want" (4); "Yes, but less than I want"(3); "No, but I would like to" (2); and "No, but I don't want to" (1). An overall participation in daily and social activities score will be calculated as well as six sub-scale scores reflecting broad categories of participation will be summed. The 6 subscales are autonomous participation- indoors (7 items, range 7-28), autonomous participation-outdoors (6 items, range 6-24), family roles (4 items, range 4-16), health (2 items, range 2-8), social relationships (4 items, range 4-16), work-education (3 items, range 3-12). Each sub-scale is calculated by adding the scores of the individual items. A higher score of each category indicates greater participation.

    Measured: Baseline, Week 6, and Week 10

  3. Life Satisfaction Questionnaire

    Standardized and validated quality of life measure that asks 11 questions about satisfaction in various areas of life, including life in general, vocation, financial situation, leisure, social/friends/family, sexual life, family life, and physical and mental health (1=very dissatisfying to 6=very satisfying). The mean score of the 11 items will be calculated for this measure.

    Measured: Baseline, Week 6, and Week 10

  4. Patient Health Questionnaire

    Measures symptoms of depression using 9 items. Participants will be asked, "Over the past 4 weeks, how often have you been bothered by any of the following problems?" and rate each symptom (eg, little interest or pleasure in doing things, poor appetite or overeating) on a 4-point scale (0=not at all; 1=Several days; 2=More than half the days 3=nearly every day). A mean score of the items will be computed with higher scores indicating higher reported symptoms of depression.

    Measured: Baseline, Week 6, and Week 10

  5. Health Care Climate Questionnaire

    Measures self-determination theory perspective on need support. Participants will respond to six items (e.g., "My exercise counselor listened to how I would like to do things regarding my exercise") on a 7-point Likert scale ranging from strongly disagree (1) to strongly agree (7). A higher mean score indicates greater perceptions of need support.

    Measured: Baseline, Week 6, and Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02833935
Sponsor's protocol ID
CraigHNF
Status last verified
Sep 2023
First submitted
8 Jul 2016
Last updated
18 Sep 2023
Data monitoring committee
No
Individual data sharing
No: Data will be shared among co-investigators.

Publications

  • Sweet SN, Rocchi M, Arbour-Nicitopoulos K, Kairy D, Fillion B. A Telerehabilitation Approach to Enhance Quality of Life Through Exercise Among Adults With Paraplegia: Study Protocol. JMIR Res Protoc. 2017 Oct 19;6(10):e202. doi: 10.2196/resprot.8047.

    PubMed 29051134

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Intervention in people with Spinal Cord Injury, run by The Craig H. Neilsen Foundation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Self-Regulation for Exercise Scale (time frame: Baseline, Week 6, and Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02833935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.

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