跳至主要内容
临床试验/NCT03152110
NCT03152110已完成不适用

Feasibility and Acceptability of Six-weeks of High Intensity Interval Training in Wheelchair Users With SCI

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Cardiopulmonary Measures

研究概览

简要总结

Spinal cord injury (SCI) is debilitating to an individual's health, functional capacity and quality of life. This contributes to a sedentary lifestyle and an elevated risk for cardiometabolic and hypokinetic diseases. While physical activity is promoted in persons with SCI to reduce incidence of secondary disabling conditions, a majority of individuals are inactive and have low levels of fitness. High intensity interval training (HIIT) is a form of exercise characterized by brief, intermittent bouts of intense exercise, separated by periods of lower intensity exercise for recovery. The level of improvements in aerobic exercise capacity following HIIT are similar to moderate-intensity continuous training, but only require a fraction of the total energy and time commitment. Little research has been done on HIIT in persons with SCI, who are unable to carry out conventional lower limb HIIT exercises. An upper extremity form of HIIT that is effective, safe, and quick could be an attractive option for these individuals. The study will look at feasibility and acceptability of a 6-week HIIT program for persons with a spinal cord injury who are untrained.

Investigators will test 10 untrained individuals with SCI/D who use a manual wheelchair full time. Prior to any testing, participants will be screened and will need to obtain a signed medical release from their physician. The screening involves asking the participant the inclusion/exclusion criteria and administering two short questionnaires related to physical activity. After obtaining the release form, participants will be scheduled for their first visit. During Visit 1, baseline testing and questionnaires will be completed. The study questionnaires will address sociodemographics, pain and health measures, general health, and physical activity. Exercise testing includes an aerobic exercise stress test (conducted following American College of Sports Medicine guidelines using an electronic ergometer) and an anaerobic (maximum power output) test. After Visit 1, participants will exercise three times per week for six weeks, following a standard HIIT protocol. Two of those sessions will be supervised by a trainer, and one session will be completed on their own. After six weeks, participants will be scheduled for Visit 2 and will complete the same evaluations as Visit 1. Additionally, participants will complete evaluations on their level of satisfaction of the training program and their likelihood to continue.

详细描述

Eligible participants will be sent a physician release form to be signed prior to study initiation. Upon receipt, the participant will be scheduled for their Visit 1, Baseline Visit and will be given the following instructions:

Do not participate in any strenuous physical activity 24 hours prior to testing.

Do not eat a large meal 4 hours prior to testing, however a light snack is okay.

Do not drink alcohol or caffeine 4 hours prior to testing. No smoking 1 hour prior to testing. Wear comfortable, loose clothing that is easy to exercise in.

Visit 1: Baseline Visit

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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
否

入选标准

  • •SCI/D which occurred at least 6 months prior to the start of the study
  • •uses a manual wheelchair as primary means of mobility (30+ hours per week)
  • •is between 18 and 65 years of age
  • •Weighs less than 250lbs
  • •lives within one hour driving time from the research center
  • •is able to perform a transfer independently to and from a wheelchair
  • •has adequate strength and upper extremity function to operate a handcycle or arm ergometer
  • •has adequate space in a safe location (i.e., home, work) to accommodate a handcycle or tabletop ergometer
  • •Receipt of a signed physicians medical release form

排除标准

  • •History of fractures or dislocations in the upper extremity from which the participant has not fully recovered
  • •Upper limb pain or injury that interferes with the ability to perform aerobic exercise
  • •No current or recent (last 6 months) participation in a structured fitness program
  • •Recent hospitalization for any reason (within the past three months)
  • •Pregnant women
  • •History of coronary artery disease, coronary bypass surgery or other cardiorespiratory events or conditions
  • •Likely to experience clinically significant autonomic dysreflexia and/ or orthostatic hypotension in response to vigorous exercise
  • •Any other conditions that the persons primary care physician deems is a contraindication to participation in arm ergometry exercise stress testing or vigorous exercise

研究组 & 干预措施

HIIT

Experimental

Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery.

干预措施: HIIT (Other)

结局指标

主要结局

Cardiopulmonary Measures

时间窗: Recorded during each training session (3x/week for 6 weeks)

Peak heart rates achieved during each work interval within a training session were averaged together and then averaged over all training sessions and expressed as a percentage of the participant's maximum heart rate obtained at baseline, during training, or at the 6 week followup whichever value was highest. The peak training heart rates were then averaged across all participants to provide an overall measure of physical effort exerted by the group during HIIT exercise.

Power

时间窗: Baseline and 6 weeks

Change in peak power output (watts) pre and post HIIT training.

HIIT Times

时间窗: To be recorded weekly, throughout study completion (3x/week for 6 weeks)

Number of HIIT Work/Rest Times (number of intervals) completed by the participants per session (averaged over all sessions and participants)

Enjoyment of HIIT

时间窗: 6 weeks

Measured using the Physical Activity Enjoyment Scale (PACES). The summative score ranges from 18 to 126 with higher scores indicating higher levels of enjoyment

Percentage of Participants Completing All Supervised Training Sessions

时间窗: To be recorded throughout study completion (6 weeks)

The number of participants who completed all the supervised training sessions (12 sessions over 6 weeks) as a percentage of the total number of participants who completed the 6 week study. The HIIT program was considered feasible if a majority of participants (80% or more) were able to complete all 12 supervised training sessions in the 6 week study time frame.

Acceptability of HIIT

时间窗: 6 weeks

Measured using the scores on one question on the Exercise Evaluation Form: "Rate your overall experience with the exercise intervention". Scores ranged from 5 (Very Satisfied) to 1 (Very Dissatisfied).

Cardiopulmonary Measures

时间窗: Baseline and 6 weeks

Change in Peak Oxygen Consumption (VO2) pre and post HIIT training (measured in mL/kg/min)

次要结局

  • Perceived Exertion(Recorded during each training session (3x/week for 6 weeks))
  • Perceived Exertion (Adapted)(To be recorded during each training session (3x/week for 6 weeks))
  • Feelings During HIIT(Recorded during each training session (3x/week for 6 weeks))

研究者

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

Alicia Koontz

Associate Professor

University of Pittsburgh

研究点 (1)

Loading locations...

相似试验