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临床试验/NCT04493606
NCT04493606Unknown不适用

Implementation of the ProACTIVE Toolkit in the Hospital and Community Setting to Improve Physical Activity Among People With Spinal Cord Injury

University of British Columbia1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年11月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
38
试验地点
1
主要终点
Change from Baseline in Leisure Time Physical Activity at 1 month, 6 months, and 1 year

研究概览

简要总结

There is a significant drop in physical activity among people with spinal cord injury in the months following discharge from rehabilitation. The ProACTIVE toolkit is a guide to promote physical activity to clients with spinal cord injury that has demonstrated potential to help address this sensitive time frame for physical inactivity. The toolkit was co- developed with 300 physiotherapists, community members with spinal cord injury, and university researchers and has been shown to improve physical activity and fitness in this population. Physiotherapists will refer clients to peer coaches with spinal cord injury who will implement the toolkit. The investigators will assess how well the toolkit is used and its effectiveness to improve physical activity levels.

详细描述

Purpose 1 (arms 1 and 2): To evaluate the effect of referral to peer-led coaching, guided by the ProACTIVE SCI intervention, on physical activity behaviour, health, and quality of life outcomes among people with SCI.

Procedure overview: Participants will complete survey measures (~45 minutes) at baseline/discharge, 2 months, 6 months post discharge, and 1-year follow-up. Participants will also complete a semi-structured interview to assess satisfaction with the intervention at 6 months. Participants in the intervention group will receive an initial assessment (~1 hour) and 10 physical activity coaching sessions (~15 minutes each). A total time commitment of ~6.5 hours is expected over one year.

Design: For pragmatic and ethical reasons, single-group, repeated measures design will be used where interested participants will receive the intervention.

Procedure: Patients who are interested in participating will be enrolled in the intervention and will receive the ProACTIVE SCI intervention coaching. Patients who are not interested in participating will be re-contacted before discharge and/or at 3 months post-discharge to gauge interest. For those who consent during their hospital stay, a two-page quick-sheet will be filled out at discharge to record any physical activity coaching information collected during their hospital stay as part of usual care. (Please see Section 9 for the "GF Strong inpatient/ form" and "GF Strong outpatient form" that is currently used in practice). The quick-sheet and any exercise prescriptions developed will be transferred to the SCI BC peers. If possible, SCI BC peers will contact the client in-person or over video-conference before discharge to begin coaching, otherwise SCI BC peers will contact the patient to begin coaching sessions in the community post-discharge. SCI BC peers will carry out the physical activity coaching sessions guided by the ProACTIVE SCI intervention with the exception that exercise prescriptions cannot be made by the peers. If exercise prescriptions are needed, referral to an adapted personal trainer in the community will be made. Coaching sessions will be provided either in-person, using video teleconferencing technology or telephone if needed. Ten 15-minute sessions will be scheduled in accordance with patient needs and readiness, however, as a general structure, one coaching session will be provided each month for months 1-3, two coaching sessions per month in months 4-6, with a follow-up before one year. The peer coaches will make up to 5 attempts to reschedule a missed coaching session.

Sample size estimate: Based on feasibility estimates calculated using number of patients admitted yearly to GF Strong (n=100), an estimated 70% discharged to home (n=70; remaining 30% discharged to long-term care or other), approximately 55% of patients willing to consent over the 3 month follow-up period, and a 20% dropout estimate (based on previous experience in conducting studies in this population) an estimated n=30 individuals will be recruited to the intervention group (see Figure 2).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •traumatic or non-traumatic spinal cord injury
  • •do not require ventilatory assistance, and
  • •have no medical contraindications to exercise identified by the care team

排除标准

  • •Uncontrolled symptoms of cardiovascular disease or cardiopulmonary problems/disease.
  • •Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory Panel classification)
  • •Any unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study.- Any cognitive dysfunction or language barrier that would prevent subjects from following English instructions.
  • •Participants may be excluded at the discretion of the principal investigator due to other, unforeseen, safety issues.

研究组 & 干预措施

Intervention Patients

Experimental

SCI patients receiving the physical activity coaching (Objective 1)

干预措施: SCI ProACTIVE Coaching (objective 1) (Other)

Intervention- Interventionists

Experimental

Interventionists receiving physical activity coaching training (Objective 2)

干预措施: Implementation Intervention (objective 2) (Behavioral)

结局指标

主要结局

Change from Baseline in Leisure Time Physical Activity at 1 month, 6 months, and 1 year

时间窗: Baseline, 1 month, 6 month, 1 year

Measures include the Leisure Time Physical Activity Questionnaire for People with SCI, which is a self-report measure that assesses minutes of mild, moderate, and vigorous intensity leisure time physical activity (i.e., activity that requires physical exertion and that one chooses to do in their free time) that is broken down into strength training and aerobic activity performed over the past seven days. Lower scores reflect less participation in leisure time physical activity. Support for the Leisure Time Physical Activity Questionnaire's criterion validity and test-retest reliability has been previously demonstrated in a sample of 103 men and women with SCI.

次要结局

  • Psychosocial predictors of physical activity(Baseline, 1 month, 6 month, 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Martin Ginis

Professor

University of British Columbia

研究点 (1)

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