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

NCT02833935 | Completed Results

• 1 other identifier: CraigHNF
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; physical activity; self-determination theory; life satisfaction

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, Week 6, and Week 10

• 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).

  Baseline, Week 6, and Week 10

Secondary Outcomes (5)

• Leisure Time Physical Activity Questionnaire for People With Spinal Cord Injury

  Baseline, Week 6, and Week 10

• Person-Perceived Participation in Daily Activities Questionnaire

  Baseline, Week 6, and Week 10

• Life Satisfaction Questionnaire

  Baseline, Week 6, and Week 10

• Patient Health Questionnaire

  Baseline, Week 6, and Week 10

• Health Care Climate Questionnaire

  Baseline, Week 6, and Week 10

Other Outcomes (4)

• Positive Affect and Negative Affect Schedule Questionnaire

  Baseline, Week 6, and Week 10

• Meaning Questionnaire

  Baseline, Week 6, and Week 10

• Social Cognitive Predictors of Leisure Time Physical Activity (LTPA) Among Adults With Spinal Cord Injury (e.g., Self-efficacy, Intentions, Action Planning)

  Baseline, Week 6, and Week 10

Study Arms (2)

Physical Activity Intervention Group

EXPERIMENTAL

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.

Behavioral: Physical Activity Intervention

Control Group

NO INTERVENTION

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.

Interventions

Physical Activity Intervention 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.

Physical Activity Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Craig H. Neilsen Foundation: lead
• McGill University: collaborator

Study Sites (1)

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

Montreal, Quebec, H2V1S4, Canada

Location

Related Publications (1)

• 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.

  PMID: 29051134 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity; Personal Satisfaction

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Results Point of Contact

• Title: Shane Sweet
• Organization: McGill University

shane.sweet@mcgill.ca

514-398-4184

Study Officials

• Shane Sweet, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 14, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 18, 2023
• Results First Posted: January 26, 2022

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)