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临床试验/NCT04075864
NCT04075864已完成不适用

Feasibility of a New Model for Exercise Prescription Combined With Behavior Modification in Cystic Fibrosis

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
pulmonary function

研究概览

简要总结

The purpose of this protocol is to begin an exercise program combined with behavioral counseling for patients who are hospitalized with a cystic fibrosis exacerbation. The exercise program will begin during the hospital stay. Beginning an exercise program during this period of reduced mobility and isolation may be an ideal time to deliver a structured exercise prescription along with a behavioral program to promote long-term adherence to exercise (structured physical activity) . Hospitalized patients have an acute awareness that their lung function is declining and may be more motivated and open to changing their behavior and adding exercise to their treatment regimen.

详细描述

During the hospitalization (T0 to T1; Figure 1, next page), participants will perform supervised exercise 6 days/wk. On each of these days, there will be a 5-10 min warm up consisting of low intensity execises for lower and upper exermity muscles. The total time per week will be between 2.5 and 3.5 hours.

Three days/wk will consist of aerobic exercise ("frequency"). The various "modes (types)" for this exercise include 1) overground ambulation (including stairs), 2) treadmill ambulation, 3) stationary cycling, or 4) repetitive body-weight exercises (e.g., "jumping jacks"). The "time (duration)" of these sessions will be 20-30 min/day. The "intensity" will be moderate (40-60% of heart rate reserve and/or perceived dyspnea/exertion of 3-5) to vigogous (60-85% of heart rate reserve and/or perceived dyspnea/exertion of 6-8). Participants will be given a HR monitor and specific "target" HR ranges based on their resting HR in standing and their age predicted maximal HR (NOTE: maximal exercise testing will not be performed); they will also be familiarized and instructed in use of the Borg CR10 scale to rate perceived dyspnea/exertion Participants should be able to "talk comfortably" during moderate intensity exercise, while talking should be "somewhat challenging" during vigorous efforts; HR, as well as perceived exertion/dyspnea and "talk test" will be monitored throughout each supervised session by trained personnel.

On alternate days, participants will perform supervised resistance exercise training (3 days/wk; "frequency"). The various "modes (types)" for this exercise include 1) body-weight exercises (e.g., lunges, squats, jumping, situps, pushups) and/or 2) resistance bands and dumbbells; exercises will target upper extremity, trunk/core, and lower extremity muscles (NOTE: specific inspiratory muscle training will not be performed). The "intensity" of these exercises will be at approximately 12-15 repetition max (that is, on the 3rd set of an exercise, the participant should have difficulty performing more than 12-15 quality (good form) repetitions of the exercise. An appropriate number of exercises will be selected such that the exercise "duration (time)" will be 20-30 min/day.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of CF
  • 18 years old or older
  • Current pulmonary exacerbation with planned UAB hospitalization for at least 10 days
  • Willing to participate in a regular, ongoing exercise program
  • Access to broadband internet

排除标准

  • Currently exercising more than 60 min/week
  • Massive hemoptysis or pneumothorax in past 3 months
  • Neuromusculoskeletal impairments that preclude exercise

结局指标

主要结局

pulmonary function

时间窗: 1 year

forced expiratory volume in 1 second

次要结局

未报告次要终点

研究者

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

Stefanie Krick MD

Assistant Professor

University of Alabama at Birmingham

研究点 (2)

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