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

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ClinicalTrials.gov Identifier: NCT01560871
Recruitment Status : Completed
First Posted : March 22, 2012
Results First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
Texas Health Resources
Information provided by (Responsible Party):
Suh-Jen Lin, Texas Woman's University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure NYHA Class II Heart Failure NYHA Class III Behavioral: High-intensity IMT plus walking Behavioral: Low-intensity IMT plus walking Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure - A Pilot Study
Study Start Date : March 2012
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560871


Locations
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United States, Texas
Outpatient heart failure transitional care clinic, Presbyterian Hospital of Dallas, Texas Health Resources
Dallas, Texas, United States, 75231
School of Physical Therapy, Texas Woman's University
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Texas Woman's University
Texas Health Resources
Investigators
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Principal Investigator: Suh-Jen Lin, PhD, PT Texas Woman's University
  Study Documents (Full-Text)

Documents provided by Suh-Jen Lin, Texas Woman's University:
Informed Consent Form  [PDF] March 14, 2017

Publications:

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Responsible Party: Suh-Jen Lin, Associate Professor, Texas Woman's University
ClinicalTrials.gov Identifier: NCT01560871    
Other Study ID Numbers: 16969
First Posted: March 22, 2012    Key Record Dates
Results First Posted: April 3, 2020
Last Update Posted: April 3, 2020
Last Verified: April 2020
Keywords provided by Suh-Jen Lin, Texas Woman's University:
Heart failure
inspiratory muscle training
physical activity
Additional relevant MeSH terms:
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Respiratory Aspiration
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes