Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure

April 1, 2020 updated by: Suh-Jen Lin, Texas Woman's University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • Outpatient heart failure transitional care clinic, Presbyterian Hospital of Dallas, Texas Health Resources
      • Dallas, Texas, United States, 75235
        • School of Physical Therapy, Texas Woman's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Low-intensity IMT Plus Walking
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.
Behavioral: Low-intensity IMT plus walking

The IMT training was 3 sets of 10 repetitions, or when the participant felt tired. Participants returned to our facility every week to reassess PImax.

For the walking program, each participant was given a pedometer and a heart rate monitor to track daily step counts and heart rate. The walking program consisted of walking every day at an intensity of "somewhat hard" to "hard" on the Borg's Rating of Perceived Exertion scale. Participants began at least 10 to 15 minutes, once to twice a day, for 7 days a week, and eventually progressed to 45-50 minutes a day by the end of the six weeks, if they could tolerate.
Experimental: High-intensity IMT Plus Walking

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

The walking program was the same as the one for the control group.
Behavioral: High-intensity IMT plus walking

The IMT intensity was set at 60% of PImax which was reassessed weekly. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at 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.

For the walking program, it was the same as the one for the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Minnesota Living With Heart Failure Questionnaire Score
Time Frame: 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.
Baseline and 6 weeks
Change From Baseline in Mean Score of Physical Component of the SF-36 Questionnaire
Time Frame: 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.
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Daily Step Counts From Week 1 to Week 6
Time Frame: Baseline and 6 weeks
Each subject was given a pedometer to record his/her step counts every day.
Baseline and 6 weeks
Respiratory Muscle Strength is Indicated by Maximal Inspiratory Pressure (PImax)
Time Frame: Baseline and 6 weeks
The inspiratory muscle strength will be measured in the unit of cmH2O by the Respiratory Muscle Pressure Meter (Micro Direct). A higher inspiratory pressure indicates a better inspiratory breathing strength.
Baseline and 6 weeks
Six-minute Walk Test Distance
Time Frame: Baseline and 6 Weeks
The six-minute walk test is a measure of cardiovascular endurance which measures how far a person can walk in 6 minutes. This test was conducted twice respectively at pre-training and at post-training to account for potential learning effect. A longer distance walked on the six-minute walking test indicates a better cardiovascular endurance.
Baseline and 6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Woman's University

Collaborators

Texas Health Resources

Investigators

  • Principal Investigator: Suh-Jen Lin, PhD, PT, Texas Woman's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 20, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16969

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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