Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001134314
Ethics application status
Approved
Date submitted
19/06/2017
Date registered
2/08/2017
Date last updated
19/03/2019
Date data sharing statement initially provided
19/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a Physical Activity Promotion Intervention for Community-Dwelling Wheelchair Users with Spinal Cord Injury.
Scientific title
Evaluating a Physical Activity Promotion Intervention for Community-Dwelling Wheelchair Users with Spinal Cord Injury.
Secondary ID [1] 292182 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 303652 0
Condition category
Condition code
Neurological 303040 303040 0 0
Other neurological disorders
Injuries and Accidents 303110 303110 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298335 0
Lifestyle
Comparator / control treatment
No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302410 0
Wheelchair movement (time) during the daily living using a the measure Wheeleri
Timepoint [1] 302410 0
The data from the primary outcome measure Wheeleri ( the time the wheelchair is moving) will be collected over the complete study duration (40 weeks including 8 week baseline phase, 16 weeks intervention phase and 16 weeks post-intervention phase). The Average daily activity (time) during the 8 baseline weeks will be compared to the average daily activity during the 16 weeks intervention (adoption) and to the last 16 weeks of post-intervention phase (maintenance).
Primary outcome [2] 302412 0
Wheelchair movement (distance) during the daily living using a the measure Wheeleri.
Timepoint [2] 302412 0
The data from the primary outcome measure Wheeleri ( the distance the wheelchair is moving) will be collected over the complete study duration (40 weeks including 8 week baseline phase, 16 weeks intervention phase and 16 weeks post-intervention phase). The average daily activity (distance) during the 8 baseline weeks will be compared to the average daily activity during the 16 weeks intervention (adoption) and to the last 16 weeks of post-intervention phase (maintenance).
Primary outcome [3] 302487 0
Physical activity levels assessed using data from ActiGpraph GT9X ( the mean counts during the daily activities using the machine learning algorithm) to identify periods of manual wheelchair propulsion,
Timepoint [3] 302487 0
The data from the primary outcome measure ActiGraphGT9X ( the mean counts during the daily activities using a machine learning algorithm) will be collected with minimum of 15 to maximum of 17 four-day monitoring periods (multiple baseline design): Baseline A: 5-7 monitoring periods, Internvetion B: 5 monitoring periods and Post intervention A2: 5 monitoring periods. The average daily counts during the 8 baseline weeks will be compared to the average daily counts during the 16 weeks intervention (adoption) and to the last 16 weeks of post-intervention phase (maintenance).
Secondary outcome [1] 335891 0
Self-efficacy assessed using Exercise self-efficacy questionnaire. Exercise Self-Efficacy Scale (ESES) is a self-report measure which includes 10 questions of how confident the person is with regard to carrying out regular physical activities and exercise. The SCI Exercise Self-Efficacy Scale (ESES) has 4-point Likert scale: 1 = not at all true, 2 = rarely true, 3 = moderately true, 4 = always true. This questionnaire has been validated in people with spinal cord injuries. The reliability of this instrument is very high with satisfactory validity (Kroll et al. 2007).
Timepoint [1] 335891 0
The data for secondary outcome measure self-efficacy will be collected during 7 data collection points during: the beginning and middle of the baseline phase (week 1 & 4), the beginning, middle and end of the intervention phase ( week 9, 17, 24); and the middle and end of the post intervention phase (32 & 40). The score results during the 8 week baseline will be compared to the average score results during the 16 weeks intervention and to the last 16 weeks of post-intervention phase.
Secondary outcome [2] 335892 0
Social support assessed using social support queationnaire with 13 items that are designed to measure perceptions of social support and satisfaction with that social support (e.g. offering company or help to do physical activities, or encouraging to do physical activities). The answers are rated on social support from family and friends to perform physical activities and the scale of this measure is 1 to 5, starting of “none” to “very often” (Sallis, Grossman et al. 1987). The total score for each question will be added together to get overall social support score. Higher score indicates higher perceived social support (score range 13-130).
Timepoint [2] 335892 0
The data for secondary outcome measure sosial support will be collected during 7 data collection points during: the beginning and middle of the baseline phase (week 1 & 4), the beginning, middle and end of the intervention phase ( week 9, 17, 24); and the middle and end of the post intervention phase (32 & 40). The score results during the 8 week baseline will be compared to the average score results during the 16 weeks intervention and to the last 16 weeks of post-intervention phase.
Secondary outcome [3] 335893 0
Decisional balance assessed using questionnaire with 16 items that concentrates on the positive and negative aspects of being physically active (e.g. influences on tiredness, sleep and body image). The psychometric properties of this measure are barriers and benefits of being physically active and the scale of this measure is 1 to 5, starting from “not important” to “extremely important” (Nigg, Rossi, Norman & Benisovich 1998). The answers of decisional balance are divided in pro and con statements. The decisional balance score will be summed con statement score subtracted from summed pro score. Numbers greater than 1 indicate benefits outweigh negatives and numbers lower than 1 indicate negatives outweigh the positives.
Timepoint [3] 335893 0
The data for secondary outcome measure decisional balance will be collected during 7 data collection points during: the beginning and middle of the baseline phase (week 1 & 4), the beginning, middle and end of the intervention phase ( week 9, 17, 24); and the middle and end of the post intervention phase (32 & 40). The score results during the 8 week baseline will be compared to the average score results during the 16 weeks intervention and to the last 16 weeks of post-intervention phase.
Secondary outcome [4] 335894 0
Health-related quality of life (HRQL) assessed using the questionnaire SF-12, which provides quantitative information about the impact of disease on HRQL. It is a multipurpose questionnaire with 12 items that are selected from the original SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions concentrates on person’s health are combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life (e.g. does the current health limit daily activities or does the pain influence on daily activities) (Ware, Kosinski, and Keller, 1996). The total score is the sum of recorded physical component summary (PCS) and mental component summary (MCS). Higher scores indicate higher perceived health related quality of life
Timepoint [4] 335894 0
The data for secondary outcome measure healt-related quality of life will be collected during 7 data collection points during: the beginning and middle of the baseline phase (week 1 & 4), the beginning, middle and end of the intervention phase ( week 9, 17, 24); and the middle and end of the post intervention phase (32 & 40). The score results during the 8 week baseline will be compared to the average score results during the 16 weeks intervention and to the last 16 weeks of post-intervention phase.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
In this study, objective data for each participant will be recorded in real time and at the end of the each data collection period will be downloaded on a personal computer, opened in Microsoft Excel and then imported into SPSS (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be generated using PASW Statistics 22 (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be reported as mean and standard deviation. The outcome measures of the study, will be plotted against time.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
2/10/2017
Date of last participant enrolment
Anticipated
1/11/2017
Actual
31/10/2017
Date of last data collection
Anticipated
30/08/2018
Actual
31/08/2018
Sample size
Target
6
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296718 0
Other
Name [1] 296718 0
Motor Accident Insurance Commission, Australia
Country [1] 296718 0
Australia
Funding source category [2] 296719 0
University
Name [2] 296719 0
The University of Queensland, Human Movement and Nutrition Sciences (HMNS).
Country [2] 296719 0
Australia
Primary sponsor type
University
Name
The University of Queensland, Human Movement and Nutrition Sciences (HMNS).
Address
School of Human Movement Studies
St Lucia campus, University of QLD, 4072
Australia
Country
Australia
Secondary sponsor category [1] 295684 0
Other
Name [1] 295684 0
Motor Accident Insurance Commission, Australia
Address [1] 295684 0
1 William St, Brisbane City QLD 4001,
Australia
Country [1] 295684 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297947 0
The University of Queensland Human Research Ethics committee (HREC)
Ethics committee address [1] 297947 0
Ethics committee country [1] 297947 0
Australia
Date submitted for ethics approval [1] 297947 0
20/06/2017
Approval date [1] 297947 0
11/08/2017
Ethics approval number [1] 297947 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75546 0
Miss Kati Susanna Karinharju
Address 75546 0
School of Human Movement Studies
St Lucia campus, University of QLD, 4072
Country 75546 0
Australia
Phone 75546 0
+61 7 33654998
Fax 75546 0
Email 75546 0
[email protected]
Contact person for public queries
Name 75547 0
Kati Susanna Karinharju
Address 75547 0
School of Human Movement Studies
St Lucia campus, University of QLD, 4072
Country 75547 0
Australia
Phone 75547 0
+61 7 33654998
Fax 75547 0
Email 75547 0
[email protected]
Contact person for scientific queries
Name 75548 0
Kati Susanna Karinharju
Address 75548 0
School of Human Movement Studies
St Lucia campus, University of QLD, 4072
Country 75548 0
Australia
Phone 75548 0
+61 7 33654998
Fax 75548 0
Email 75548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.