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

NCT ID: NCT02833935

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-12-31

Brief 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). 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).

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Physical Activity Intervention Group

Participants 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.

Group Type: EXPERIMENTAL

Physical Activity Intervention

Intervention Type: BEHAVIORAL

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.

Control Group

Control 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical Activity Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

The Craig H. Neilsen Foundation

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shane Sweet

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shane Sweet, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

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

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29051134 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CraigHNF

Identifier Type: -

Identifier Source: org_study_id