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

NCT01560871 | Completed Results DMC

• 1 other identifier: 16969
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure NYHA Class II; Heart Failure NYHA Class III

Keywords

Heart failure; inspiratory muscle training; physical activity

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 6 weeks

• 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.

  Baseline and 6 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Behavioral: Low-intensity IMT plus walking

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.

Behavioral: High-intensity IMT plus walking

Interventions

High-intensity IMT plus walking BEHAVIORAL

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.

High-intensity IMT Plus Walking

Low-intensity IMT plus walking BEHAVIORAL

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.

Low-intensity IMT Plus Walking

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Texas Woman's University: lead
• Texas Health Resources: collaborator

Study Sites (2)

Outpatient heart failure transitional care clinic, Presbyterian Hospital of Dallas, Texas Health Resources

Dallas, Texas, 75231, United States

Location

School of Physical Therapy, Texas Woman's University

Dallas, Texas, 75235, United States

Location

Related Publications (11)

• 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.

  PMID: 23219302 BACKGROUND

• 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.

  PMID: 30806695 BACKGROUND

• 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.

  PMID: 21798015 BACKGROUND

• 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.

  PMID: 19706192 BACKGROUND

• 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.

  PMID: 30522438 BACKGROUND

• 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.

  PMID: 22993500 BACKGROUND

• 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.

  PMID: 23512093 BACKGROUND

• 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.

  PMID: 1529875 BACKGROUND

• 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.

  PMID: 11594639 BACKGROUND

• 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.

  PMID: 10412550 BACKGROUND

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

  PMID: 7154893 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Results Point of Contact

• Title: Dr. Suh-Jen Lin
• Organization: Texas Woman's University

slin@twu.edu

214-689-7718

Study Officials

• Suh-Jen Lin, PhD, PT

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: April 3, 2020
• Results First Posted: April 3, 2020

Record last verified: 2020-04

Locations

US (2)