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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02833935

Enrollment

Registered

2016-07-14

Start date

2016-08-31

Completion date

2017-12-31

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

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

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.

Interventions

BEHAVIORALPhysical 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Treatment Self-Regulation for Exercise Scale	Baseline, Week 6, and Week 10	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.
Psychological Needs for Exercise Questionnaire	Baseline, Week 6, and Week 10	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).

Secondary

Measure	Time frame	Description
Health Care Climate Questionnaire	Baseline, Week 6, and Week 10	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.
Leisure Time Physical Activity Questionnaire for People With Spinal Cord Injury	Baseline, Week 6, and Week 10	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.
Person-Perceived Participation in Daily Activities Questionnaire	Baseline, Week 6, and Week 10	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.
Life Satisfaction Questionnaire	Baseline, Week 6, and Week 10	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.
Patient Health Questionnaire	Baseline, Week 6, and Week 10	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.

Other

Measure	Time frame	Description
Meaning Questionnaire	Baseline, Week 6, and Week 10	Measures meaningful life experience capturing broader aspects of well-being/quality of life. This 5-item scale asks participants to rate their responses from 1 (absolutely untrue) to 7 (absolutely true). A higher score indicated greater reported meaning.
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	This measure consists of a battery of short questionnaires assessing psychosocial predictors of leisure time exercise activity such as self-efficacy, intentions, and action planning among adults with spinal cord injury. Intentions were measured with 2 items and participants responded on a scale (1-strongly disagree 7-strongly agree). Action planning was measured with 4 items and participants responded on a scale (1-definitely false 7-definitely true). Barrier self efficacy was measured with 6 items and task efficacy was measured with 8 items and participants responded on a scale (1-not at all confident 7-completely confident). A higher score on each of the questionnaires indicated higher levels (e.g., greater intentions, self-efficacy, and action planning).
Behavioural Regulation in Exercise Questionnaire	Baseline, Week 6, and Week 10	Measure to assess changes in all 6 motivational regulations as per self-determination theory asking reasons why individuals engage in exercise/physical activity during the intervention. Participants will respond to 23 items (e.g, I don't see why I should have to exercise), on a 5-point Likert scale ranging from 0 (not true for me) to 4 (very true for me), covering the types of motivational regulations on the self-determination continuum. The mean score of participants' autonomous and controlled motivation will be calculated. A higher mean score indicated a higher level of that type of motivation. Outcome measure data are not presented because of missingness.
Positive Affect and Negative Affect Schedule Questionnaire	Baseline, Week 6, and Week 10	A measure of affective experience capturing broader aspects of well-being/quality of life

Countries

Canada

Participant flow

Participants by arm

Arm	Count
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. 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.	12
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.	12
Total	24

Baseline characteristics

Characteristic	Control Group	Total	Physical Activity Intervention Group
Age, Continuous	53 years STANDARD_DEVIATION 11.29	50.50 years STANDARD_DEVIATION 12.34	49.64 years STANDARD_DEVIATION 12.64
Cause of Spinal Cord Injury Non-Traumatic	4 Participants	8 Participants	4 Participants
Cause of Spinal Cord Injury Traumatic	8 Participants	16 Participants	8 Participants
Language Anglophone	3 Participants	7 Participants	4 Participants
Language Francophone	9 Participants	17 Participants	8 Participants
Mobility Mode Manual Wheelchair	7 Participants	15 Participants	8 Participants
Mobility Mode Other (e.g., cane)	4 Participants	7 Participants	3 Participants
Race/Ethnicity, Customized Race Other	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Race White	11 Participants	23 Participants	12 Participants
Region of Enrollment Canada	10 participants	21 participants	11 participants
Region of Enrollment United States	2 participants	3 participants	1 participants
Sex: Female, Male Female	2 Participants	7 Participants	5 Participants
Sex: Female, Male Male	10 Participants	16 Participants	6 Participants
Years since Spinal Cord Injury	15.10 years STANDARD_DEVIATION 10.89	15.45 years STANDARD_DEVIATION 12.85	15.8 years STANDARD_DEVIATION 14.51

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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).