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Evaluating a Physical Activity Promotion Intervention for Community-Dwelling Wheelchair Users with Spinal Cord Injury.

Evaluating a Physical Activity Promotion Intervention for Community-Dwelling Wheelchair Users with Spinal Cord Injury.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001134314
Acronym
N/A
Enrollment
6
Registered
2017-08-02
Start date
2017-10-02
Completion date
2017-10-31
Last updated
2019-07-15

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

Conditions

None listed

Brief summary

Individuals with a spinal cord injury do not participate in sufficient physical activity to meet the recommended guidelines for good health. To promote physical activity, physical activity interventions are needed. The aim of this study is to evaluate the efficacy of a physical activity promotion intervention for community-dwelling adults with a spinal cord injury who use a wheelchair as their primary means of locomotion. The aim of the intervention is increase physical activity participation. Primary outcomes of this study will be increased amount of physical activity that the participants are conducting during their daily living. The secondary outcomes will be self-efficacy, social support and decisional balance in physical activity and health-related quality of life. The study design will be based on the single-subject research design guidelines for determining sample size and protocol for sampling behaviour (Romeiser Logan, Hickman et al. 2008). Each participant will participate in the study for a total of 40 weeks. The study will be conducted in the home and community environment of the participant. During the 40-week study, participant will be asked to wear two physical activity monitors: the wheelchair mounted device (Wheeleri) and a wrist worn accelerometer which has the look and feel of a wristwatch (ActiGraph GT9X). Participants will also be asked to complete four questionnaires measuring mediators of physical activity participation (including self-efficacy, social support and decisional balance) and measures of health related quality of life. The study protocol comprises 3 phases: baseline phase (8 weeks); intervention phase (16 weeks); and post intervention phase (16 weeks). During the 8-week baseline phase, participant’s physical activity will be monitored while they continue with their normal behaviour in order to determine their baseline level of physical activity. The baseline phase will be followed by a 16-week intervention. The intervention combines a stage-matched lifestyle physical activity intervention, structured exercise prescription and community integration delivered utilising a community-based rehabilitation. During the 16-week intervention period, participants will receive 12 face to face visits of a one hour duration in their own home or local community. In between these sessions they will also receive phone/online support as required (Dunn, Andersen et al. 1998). Session frequency will diminish over the 16-week period, with a reduced number of sessions as a result of an increased emphasis on maintenance of physical activity participation including fostering independence and self-management. The intervention phase will be followed by a 16-week non-contact post intervention period during which physical activity will be monitored in order to determine the extent to which any increases in physically active behaviour achieved during the intervention are maintained.

Interventions

Each participant will participate in the study for a total of 40 weeks. The study will be conducted in the home and community environment of the participant. During the 40-week study, participant will be asked to wear two physical activity monitors: the wheelchair mounted device (Wheeleri) and a wrist worn accelerometer. The Wheeleri will attached to the wheelchair the whole 40-week period and the ActiGraph will be worn minimum of 15 to maximum of 17 four-day monitoring periods (60-68 days), du

Each participant will participate in the study for a total of 40 weeks. The study will be conducted in the home and community environment of the participant. During the 40-week study, participant will be asked to wear two physical activity monitors: the wheelchair mounted device (Wheeleri) and a wrist worn accelerometer. The Wheeleri will attached to the wheelchair the whole 40-week period and the ActiGraph will be worn minimum of 15 to maximum of 17 four-day monitoring periods (60-68 days), during the whole 40-week period. These monitors will be used to measure the participant’s physical activity during daily activities like wheelchair propulsion and stationary upper body activities. Participants will also be asked to complete four questionnaires measuring mediators of physical activity participation (including self-efficacy, social support and decisional balance) and measures of health related quality of life at 7 time points spread equally over the 40 week study protocol. At the conclusion of the intervention, participants will be asked to participate in a semi-structured interview regarding their perceptions of the intervention program. The study protocol comprises 3 phases: baseline phase (8 weeks); intervention phase (16 weeks); and post intervention phase (16 weeks). Phase A: No intervention (Baseline) During the 8-week baseline phase, participant’s physical activity will be monitored while they continue with their normal behaviour in order to determine their baseline level of physical activity. Phase B: Intervention The baseline phase will be followed by a 16-week intervention. The intervention will be delivered using a community-based rehabilitation model which aims to enhance the natural support systems within the participant’s home and community environment. During the 16-week intervention period, participants will receive 12 face to face visits of a one hour duration in their own home or local community. In between these sessions they will also receive phone/online support as required. Session frequency will diminish over the 16-week period, with a reduced number of sessions as a result of an increased emphasis on maintenance of physical activity participation including fostering independence and self-management. This intervention implementation comprises of 4 Steps: 1. Step. Pre-participation assessment: participant will have one 2 hour session at their home with primary investigator where they will have to answer different questionnaires including 1) an assessment of physiological, personal and environmental factors that may influence on physical activity participation such as - the functional abilities and limitations related to disability and functioning such as ability to do wheelchair propulsion, body lifts and exercise movements with and without the chair - the personal abilities, interests and skills to carry out physical activities and personal history and experiences in physical activity such as gardening, outdoor activities, water activities, ball games, gym work out, dance. - the accessibility level of participant's home and local community to carry out physical activities such as free space at home and garden, transportation to local community activities and accessibility at the community venues and facilities. 2) assessment of stage of change where participant's motivational readiness for being physically active will be evaluated. Pre-assessment also includes information sharing activities including the matrial (video, paper and oral material) related to the definition and benefits of physical activity participation. Step 2. A In lifestyle PA intervention sessions: participant will have 12 1 hour sessions during 16 weeks intervention period at their home with primary investigator. During these sessions they will be using different stage-matched behavior change strategies; (e.g. including but not limited to information sharing, personal time auditing, value identification and barrier identification and resolution); Step 3. Structured exercise prescription: during the 16 weeks intervention period participant will be encouraged to do different physical activities including structured exercise prescription (in terms of frequency, intensity, time and type) and/or and community based physical activity participation (e.g. going to the local pool or gym or attending an art class); Step 4. Tailored relapse prevention: during the Lifestyle PA sessions primary investigator will go through together with the participant tailored relapse prevention strategies to foster physical activity maintenance following the withdrawal of the intervention. The intervention aims to help participants to find activities that they can complete which are enjoyable, effective for improving their health and which they will be able to maintain at the conclusion of the intervention. The activities selected will be the choice of their participant and will work within their resources (e.g., access, time and money). This intervention has been demonstrated to successfully increase physical activity adoption in adults with brain impairment. The intervention will be delivered by the primary investigator Kati Karinharju, who has experience in exercise prescription for individuals with a disability and the use of behaviour change strategies for increasing PA. The principal investigator has a Master degree in both sport sciences and adapted physical activities and she has been working as Senior lecturer (In Finland) in the field of adapted physical activity. She has extensive experience (over 15 years) working in the area of physical activities for the populations included in this research, including high care participants. She is also experienced using devices and protocols used with used with the populations included in this project. This project also includes co-project workers with high experience and competence in these relevant areas. Given the project team's considerable experience, plus additional training as needed, will assure quality research processes and assure the comfort and safety of the project participants. Phase A2: No Intervention (Post intervention) The intervention phase will be followed by a 16-week non-contact post intervention period during which physical activity will be monitored in order to determine the extent to which any increases in physically active behaviour achieved during the intervention are maintained.

Sponsors

The University of Queensland, Human Movement and Nutrition Sciences (HMNS).
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

This study aims to recruit 6 participants with spinal cord injuries. This study will include male and female adults who at the time of enrolment: - have a spinal cord injury; - are aged 18-55; - use a manual wheelchair or power-assisted manual wheelchair for daily activities at least some of the time. They may use power chairs or other mobility devices at other times; - are insufficiently physically active for health at time of recruitment; and - are medically fit to undertake at least moderate intensity physical activity, as determined by the Adult Pre-exercise Screening System (APSS) (Exercise and Sport Science Australia (ESSA) 2016).

Exclusion criteria

This study will exclude individuals who have a diagnosed cognitive impairment, intellectual disability or mental illness that restricts their ability to participate in the behaviour change activities integral to the intervention.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026