search
Back to results

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

Primary Purpose

Heart Failure NYHA Class II, Heart Failure NYHA Class III

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-intensity IMT plus walking
Low-intensity IMT plus walking
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure NYHA Class II focused on measuring Heart failure, inspiratory muscle training, physical activity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Low-intensity IMT Plus Walking

High-intensity IMT Plus Walking

Arm Description

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.

Inspiratory Muscle Training (IMT) intensity was set at 60% PImax. The walking program was the same as the one for the control group.

Outcomes

Primary Outcome Measures

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

Mean Daily Step Counts From Week 1 to Week 6
Each subject was given a pedometer to record his/her step counts every day.
Respiratory Muscle Strength is Indicated by Maximal Inspiratory Pressure (PImax)
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.
Six-minute Walk Test Distance
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.

Full Information

First Posted
March 20, 2012
Last Updated
April 1, 2020
Sponsor
Texas Woman's University
Collaborators
Texas Health Resources
search

1. Study Identification

Unique Protocol Identification Number
NCT01560871
Brief Title
Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure
Official Title
Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
Collaborators
Texas Health Resources

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Keywords
Heart failure, inspiratory muscle training, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-intensity IMT Plus Walking
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
High-intensity IMT Plus Walking
Arm Type
Experimental
Arm Description
Inspiratory Muscle Training (IMT) intensity was set at 60% PImax. The walking program was the same as the one for the control group.
Intervention Type
Behavioral
Intervention Name(s)
High-intensity IMT plus walking
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low-intensity IMT plus walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Minnesota Living With Heart Failure Questionnaire Score
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in Mean Score of Physical Component of the SF-36 Questionnaire
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Mean Daily Step Counts From Week 1 to Week 6
Description
Each subject was given a pedometer to record his/her step counts every day.
Time Frame
Baseline and 6 weeks
Title
Respiratory Muscle Strength is Indicated by Maximal Inspiratory Pressure (PImax)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Six-minute Walk Test Distance
Description
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.
Time Frame
Baseline and 6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suh-Jen Lin, PhD, PT
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient heart failure transitional care clinic, Presbyterian Hospital of Dallas, Texas Health Resources
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
School of Physical Therapy, Texas Woman's University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23219302
Citation
Gheorghiade M, Vaduganathan M, Fonarow GC, Bonow RO. Rehospitalization for heart failure: problems and perspectives. J Am Coll Cardiol. 2013 Jan 29;61(4):391-403. doi: 10.1016/j.jacc.2012.09.038. Epub 2012 Dec 5.
Results Reference
background
PubMed Identifier
30806695
Citation
Van Spall HGC, Lee SF, Xie F, Oz UE, Perez R, Mitoff PR, Maingi M, Tjandrawidjaja MC, Heffernan M, Zia MI, Porepa L, Panju M, Thabane L, Graham ID, Haynes RB, Haughton D, Simek KD, Ko DT, Connolly SJ. Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: The PACT-HF Randomized Clinical Trial. JAMA. 2019 Feb 26;321(8):753-761. doi: 10.1001/jama.2019.0710.
Results Reference
background
PubMed Identifier
21798015
Citation
Tudor-Locke C, Craig CL, Brown WJ, Clemes SA, De Cocker K, Giles-Corti B, Hatano Y, Inoue S, Matsudo SM, Mutrie N, Oppert JM, Rowe DA, Schmidt MD, Schofield GM, Spence JC, Teixeira PJ, Tully MA, Blair SN. How many steps/day are enough? For adults. Int J Behav Nutr Phys Act. 2011 Jul 28;8:79. doi: 10.1186/1479-5868-8-79.
Results Reference
background
PubMed Identifier
19706192
Citation
Tudor-Locke C, Hart TL, Washington TL. Expected values for pedometer-determined physical activity in older populations. Int J Behav Nutr Phys Act. 2009 Aug 25;6:59. doi: 10.1186/1479-5868-6-59. Erratum In: Int J Behav Nutr Phys Act. 2009 Oct 09;6:65.
Results Reference
background
PubMed Identifier
30522438
Citation
Bailly L, Mosse P, Diagana S, Fournier M, d'Arripe-Longueville F, Diagana O, Gal J, Grebet J, Moncada M, Domerego JJ, Radel R, Fabre R, Fuch A, Pradier C. "As du Coeur" study: a randomized controlled trial on quality of life impact and cost effectiveness of a physical activity program in patients with cardiovascular disease. BMC Cardiovasc Disord. 2018 Dec 6;18(1):225. doi: 10.1186/s12872-018-0973-3.
Results Reference
background
PubMed Identifier
22993500
Citation
Lin SJ, McElfresh J, Hall B, Bloom R, Farrell K. Inspiratory muscle training in patients with heart failure: a systematic review. Cardiopulm Phys Ther J. 2012 Sep;23(3):29-36.
Results Reference
background
PubMed Identifier
23512093
Citation
Marco E, Ramirez-Sarmiento AL, Coloma A, Sartor M, Comin-Colet J, Vila J, Enjuanes C, Bruguera J, Escalada F, Gea J, Orozco-Levi M. High-intensity vs. sham inspiratory muscle training in patients with chronic heart failure: a prospective randomized trial. Eur J Heart Fail. 2013 Aug;15(8):892-901. doi: 10.1093/eurjhf/hft035. Epub 2013 Mar 19.
Results Reference
background
PubMed Identifier
1529875
Citation
Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Pimobendan Multicenter Research Group. Am Heart J. 1992 Oct;124(4):1017-25. doi: 10.1016/0002-8703(92)90986-6.
Results Reference
background
PubMed Identifier
11594639
Citation
Middel B, Bouma J, de Jongste M, van Sonderen E, Niemeijer MG, Crijns H, van den Heuvel W. Psychometric properties of the Minnesota Living with Heart Failure Questionnaire (MLHF-Q). Clin Rehabil. 2001 Oct;15(5):489-500. doi: 10.1191/026921501680425216.
Results Reference
background
PubMed Identifier
10412550
Citation
Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
Results Reference
background
PubMed Identifier
7154893
Citation
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs