Heart Failure NYHA Class III Clinical Trial
Official title:
Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure - A Pilot Study
NCT number | NCT01560871 |
Other study ID # | 16969 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2012 |
Est. completion date | January 2018 |
Verified date | April 2020 |
Source | Texas Woman's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | January 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Outpatient heart failure transitional care clinic, Presbyterian Hospital of Dallas, Texas Health Resources | Dallas | Texas |
United States | School of Physical Therapy, Texas Woman's University | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Woman's University | Texas Health Resources |
United States,
Bailly L, Mossé 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. — View Citation
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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. — View 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. — View Citation
Marco E, Ramírez-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. — View 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. — View Citation
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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. Review. — View Citation
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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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Mean Daily Step Counts From Week 1 to Week 6 | Each subject was given a pedometer to record his/her step counts every day. | Baseline and 6 weeks | |
Secondary | 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. | Baseline and 6 weeks | |
Secondary | 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. | Baseline and 6 Weeks |
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