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临床试验/NCT01560871
NCT01560871已完成不适用

Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure - A Pilot Study

Texas Woman's University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2012年3月1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
16
试验地点
2
主要终点
Change From Baseline in Mean Minnesota Living With Heart Failure Questionnaire Score

研究概览

简要总结

Individuals with chronic heart failure need a "safe and effective" exercise program that could enhance their quality of life. In this study, we examined whether an experimental exercise program of autonomous walking and high-intensity Inspiratory Muscle Training (IMT) could result in better effects on respiratory muscle strength (PImax), cardiovascular endurance, quality of life, and physical activity, when compared to autonomous walking and "sham" IMT program, in adults with chronic heart failure.

详细描述

Participants were recruited from the outpatient heart failure transitional care clinic at the Presbyterian Hospital of Dallas and other local heart failure support groups. Flyers were distributed to cardiologists, nurse practitioners, and local heart failure support groups in the Dallas/Ft Worth area. Cardiologists and nurse practitioners were aware of the scope of the study and its inclusion and exclusion criteria of research participants. Potential research participants could then call the research team for further information.

Participants came to our facility for the initial evaluation session, where a history interview was conducted to gather demographic data, such as age, gender, height, weight, race/ethnicity, and past medical/surgical history. The following baseline data were then collected: a) two trials of the six-minute walk test, b) respiratory muscle strength indicated by maximal inspiratory pressure (PImax), and two quality of life questionnaires. During the walk test, heart rate and heart rhythms were continuously monitored via a holter monitor. During the rest breaks, research participants filled out two quality of life questionnaires (SF-36, Minnesota Living with Heart Failure Questionnaire).

Each participant was randomly assigned to one of the two groups: a) the autonomous walking program with a high-intensity Inspiratory Muscle Training (IMT) program, or b) the autonomous walking program with a sham IMT. The training threshold for the experimental IMT group was trained at 60%PImax which was reassessed at weekly follow ups. The frequency of training was 5x/week (1x/day preferred) for 6 interval levels at each session (6 inspiratory efforts in each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. The intensity of sham IMT was set at fixed 15% PImax. Research participants were blinded to the group assignment. The time commitment for IMT was about 15-20 minutes a session per day at home. Weekly follow up was conducted at the School of Physical Therapy in Dallas to reassess PImax, collect the log of daily step count, and discuss about the walking program. Every participant was given a breathing device for inspiratory muscle training.

Each participant was given a pedometer and a heart rate monitor to track their daily step counts and heart rate during the walking session. The walking program consisted of walking daily at an intensity of "somewhat hard" to "hard" on the Borg's Rating of Perceived Exertion (RPE) scale. Participants were encouraged to walk 10 to 15 minutes, once to twice a day initially, then progressed to about 45-50 minutes a day by week six, if they could tolerate. At the end of 6 weeks, these participants returned to our facility for the final evaluation session.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adults with chronic heart failure (NYHA Functional Class II-III)
  • •BMI < 35 kg/m^2
  • •Age: 18 to 90 years
  • •walk independently with or without an assisted device
  • •hospital discharge for CHF within a year.

排除标准

  • •ECG with uncontrolled ventricular arrhythmia
  • •bronchiectasis
  • •limited walking ability due to neurologic or orthopedic impairments of the legs

研究组 & 干预措施

Low-intensity IMT Plus Walking

Sham Comparator

Inspiratory Muscle Training (IMT) intensity was set at 15% PImax. The walking program consisted of walking every day at an intensity of "somewhat hard" to "hard" on the Borg's Rating of Perceived Exertion (RPE) scale. Participants were encouraged to walk at 10 to 15 minutes, once to twice a day initially, then progressed to 45-50 minutes a day by the end of the six weeks, if they could tolerate.

干预措施: Low-intensity IMT plus walking (Behavioral)

High-intensity IMT Plus Walking

Experimental

Inspiratory Muscle Training (IMT) intensity was set at 60% PImax.

The walking program was the same as the one for the control group.

干预措施: High-intensity IMT plus walking (Behavioral)

结局指标

主要结局

Change From Baseline in Mean Minnesota Living With Heart Failure Questionnaire Score

时间窗: Baseline and 6 weeks

This questionnaire includes 21 questions which ask how much the heart condition affected the patient's life during the past month. Each question has 5 optional answers with the scores ranging from 0 to 5. A higher score indicates a worse outcome. The minimum overall score of the questionnaire is 0 and the maximum score is 105. A higher overall score on the Minnesota Living with Heart Failure Questionnaire indicates a worse outcome.

Change From Baseline in Mean Score of Physical Component of the SF-36 Questionnaire

时间窗: Baseline and 6 weeks

The SF-36 quality of life questionnaire (short form) was used. A higher score of the SF-36 questionnaire indicates a better outcome (i.e., lower disability). The range of overall score on the SF-36 questionnaire is from 0 to 100.

次要结局

  • Mean Daily Step Counts From Week 1 to Week 6(Baseline and 6 weeks)
  • Respiratory Muscle Strength is Indicated by Maximal Inspiratory Pressure (PImax)(Baseline and 6 weeks)
  • Six-minute Walk Test Distance(Baseline and 6 Weeks)

研究者

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

Suh-Jen Lin

Associate Professor

Texas Woman's University

研究点 (2)

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