跳至主要内容
临床试验/NCT05989906
NCT05989906Enrolling By Invitation不适用

Feasibility of a Sprint Interval Training Program During Inpatient Spinal Cord Injury Rehabilitation: A Pilot Randomized Controlled Trial

University of Washington2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
32
试验地点
2
主要终点
Total physical activity (vector magnitude) per week

研究概览

简要总结

This study will assess the feasibility and efficacy of 3 treatments to increase physical activity during and after inpatient rehabilitation (IPR) for new spinal cord injuries:

  1. Program of sprint interval training (SIT) on an arm crank ergometer during IPR
  2. SIT + Provision of an arm ergometer (ERGO) for home use
  3. SIT + ERGO for home use + Motivational interviewing to increase adherence to exercise during and after IPR.

The primary outcome is minutes per week of moderate to vigorous physical activity at 6 months after IPR discharge. Secondary outcomes include peak power on the 6-Minute Arm Test at IPR discharge and self-reported physical activity, depression, fatigue, pain, community participation, and quality of life at 6 months after IPR discharge. The investigators will obtain data on feasibility, acceptability, and perceived benefits of the treatments from stakeholders. The results of this pilot study will inform the design of a larger randomized trial.

详细描述

Description of the Sprint Interval Training Condition

The SIT treatment procedures will parallel the procedures used in the successful comparative effectiveness trial of SIT versus Moderate Intensity Continuous Training (MICT) during IPR in Canada.

SIT participants will be trained to use an ergometer on a Monark 881 mechanically braked arm ergometer purchased for the study. The Monark will be mounted on a rolling table designed for this purpose, so training can take place in patient rooms or in one of several small therapy rooms adjacent to the inpatient rehabilitation unit. Sessions will begin with the physical or occupational therapist showing the participant the RPE scale (Borg 6-20) posted behind the ergometer and instructing the participant in how to report perceived exertion during each session. The therapist will position the ergometer axle at shoulder height and close enough to the participant to maintain slight elbow flexion. They will attach the heart rate monitor, validate initial recordings, assess resting RPE, and record resting HR and blood pressure. They will have the participant begin a two-minute warm-up at a self-selected speed and zero resistance followed by three 20-second intervals of all-out effort interspersed by 120 seconds of active recovery at zero resistance. During each interval, participants will be instructed to achieve a cadence of approximately 100 revolutions per minute for persons with paraplegia and approximately 85 revolutions per minute for people with tetraplegia. The therapist will adjust ergometer resistance as needed to maintain RPE ratings between 15-17. Rating of perceived exertion is a valid method to prescribe interval exercise intensity and preferable to HR. Heart rate will be recorded continuously and averaged over the entire training session excluding the warm-up and recovery periods. RPE will be measured at the end of each sprint interval training session. To accommodate training adaptation over time, the resistance on the ergometer will be increased to maintain a peripheral RPE of 16. SIT training was well-tolerated and safe in the prior IPR trial as well as in several post-acute SCI studies. Hypotension is a potential adverse event in this setting, especially immediately post-exercise. Thus, sessions will include blood pressure monitoring and surveillance for symptoms of hypotension during and after the exercise session. Adverse events will be reported to the research team for review by the DSMB. SIT training will take place approximately 3 times per week.

Description of the Home Arm Ergometer Condition

Participants randomized to receive ERGO will also take part in SIT approximately 3 times per week. Participants will undergo at least one SIT session on the consumer grade ergometer under supervision of the physical or occupational therapist. The therapist/team will demonstrate all the features of the device set up, use, and resistance adjustment to the patient and caregiver (if available). The therapist/team will problem-solve barriers to home use prior to discharge and contact the patient soon after discharge to help resolve additional problems that may have emerged. The patient will be sent home with an exercise log-sheet like the one used during IPR to guide continued training. Prior to discharge the study team will arrange to have the ergometer given to or shipped to the participant's discharge residence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Research study assistant collecting self-report outcomes and Principal Investigators will be masked to participant's study group.

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

入选标准

  • Adults with SCI
  • SCI below C2
  • undergoing acute IPR for SCI at Harborview Medical Center
  • Able to use an arm ergometer

排除标准

  • poorly controlled type II diabetes
  • unstable cardiovascular disease
  • shoulder injury
  • any other medical condition that would preclude safe participation in study procedures.

结局指标

主要结局

Total physical activity (vector magnitude) per week

时间窗: 7 day assessment (at 6 month timepoint)

To compare the effect sizes (Cohen's d) of each of the three treatment conditions: (1) SIT alone, (2) SIT+ERGO, and (3) SIT+ERGO+MI relative to usual care on the primary outcome, total physical activity (vector magnitude) per week at 6 months post discharge measured by an Actigraph GT3X worn on the non-dominant wrist for 7 days.

Total number of Ergometer (ERGO) sessions that participants complete between treatment completion and 6 month follow up

时间窗: 6 Month Follow Up (week 24)

Among patients who received a home ergometer, the investigators will assess how many sessions of SIT the participants completed between treatment completion (in hospital) and the 6-month timepoint.

Percentage of participants that complete at least six Sprint Interval Training (SIT) sessions

时间窗: Treatment Completion (week 3)

Investigators will assess the total number and percentage of participants that complete at least six SIT sessions, the minimum number of SIT sessions associated with a significant increase in physical capacity among SCI participants.

Percentage of participants that adhere to Sprint Interval Training sessions and received Motivational Interviewing (MI) sessions

时间窗: 6 Month Follow Up (week 24)

Investigators will assess the total number and percentage of participants that completed at least 75% of the Sprint Interval Training sessions among participants that received Motivational Interviewing.

次要结局

  • Oral Symbol Digit Modalities Test (SDMT)(Baseline (week 0), Treatment Completion (week 4))
  • Leisure Time Physical Activity (LTPA)(Treatment Completion (week 4), 6 Month Follow Up (week 24))
  • SCI Quality of Life(Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24))
  • Generalized Anxiety Disorder (GAD-7)(Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24))
  • Acceptability(Treatment Completion (week 4), 6 Month Follow Up (week 24))
  • Patient Reported Outcome Measures Information System (PROMIS) Fatigue Short Form(Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24))
  • Physical Activity Enjoyment Scale (PACES)(Within 5 minutes after each Sprint Interval Training session during first 3 weeks of study (weeks 0-3))
  • Adverse Events (Safety)(At the end of each Sprint Interval Training (SIT) session during weeks 0-4 of the study and at the end of the 6-minute arms tests (weeks 0-4))
  • Peak power on the 6-Minute Arm Test (6-MAT)(Self-reported physical exertion at the end of 6 minutes of physical exercise on the arm ergometer at Baseline (week 0) and at Treatment Completion (week 4))
  • Patient Health Questionnaire (PHQ-9)(Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24))
  • Numerical Rating Scale (NRS) of Worst/Average Pain(Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24))
  • Wheelchair Users Shoulder Pain Inventory (WUSPI)(Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24))
  • Spinal Cord Injury Exercise Self-Efficacy(Baseline (week 0), Treatment Completion (week 4), 6 Month Follow Up (week 24))

研究者

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

Deborah Crane

Associate Professor, School of Medicine

University of Washington

研究点 (2)

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