Clinical trial NCT05349786: Physical Activity Program on Clinical Output in Heart Failure
Official title: The Effect of the Physical Activity Program on Quality of Life, Functional Capacity and Mortality Risk Level in Individuals With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Nursing Caries
Keywords: Heart failure
Physical activity
Functional capacity
Quality of life
NT-proBNP
Mortality risk level
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: This study was carried out to determine the effect of physical activity program applied to individuals with heart failure on quality of life, functional capacity and mortality risk level.

Objective: The study, which was conducted as a randomized controlled experimental study, was completed with a total of 40 HF patients, 20 of whom were interventions and 20 were controls. A physical activity program lasting at least 30 minutes each session was applied to HF patients in the intervention group, three days a week for three months, and the walks of the patients were followed by a pedometer.

Detailed description: Background: This study was carried out to determine the effect of physical activity program applied to individuals with heart failure on quality of life, functional capacity and mortality risk level.

Objective: The study, which was conducted as a randomized controlled experimental study, was completed with a total of 40 HF patients, 20 of whom were interventions and 20 were controls. A physical activity program lasting at least 30 minutes each session was applied to HF patients in the intervention group, three days a week for three months, and the walks of the patients were followed by a pedometer. At the same time, a monthly home visit and weekly phone call were made to the patients. No intervention was applied to the patients in the control group, apart from weekly phone calls. All patients were receiving optimal stable HF therapy.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age,
* Class I, II, III according to NYHA classification,
* Without any diagnosis of musculoskeletal deformity or disease that may prevent them from doing physical activity,
* Hypertension stage 1 and 2,
* Stable chronic disease processes such as diabetes,
* Patients whose treatment for these diagnoses has not been changed in the last month,
* Dyspnea status less than 4-5 degrees according to the Modified Borg Scale,
* Cognitive competence,
* At least primary school graduates

Exclusion Criteria:

* Known and diagnosed moderate or severe mitral/aortic regurgitation, hypertrophic obstructive cardiomyopathy, uncontrollable arrhythmia (atrial fibrillation etc.), bundle branch block on ECG,
* Acute myocardial infarction in the last three months,
* Unstable angina pectoris, pacemaker, valve surgery, coronary artery bypass surgery history, newly diagnosed or suspected thromboembolic event,
* Diagnosed with cerebrovascular and peripheral vascular insufficiency, other chronic diseases (such as chronic obstructive pulmonary disease, chronic kidney failure, pulmonary emphysema, rheumatic valve disease, cancer diagnosis),
* Chronic fatigue syndrome

Primary outcomes:
measure: Quality of Life Level
timeFrame: Change from baseline scores at the first month, second month, third month scores
measure: Functional Capacity Level
timeFrame: Change from baseline scores at the first month, second month, third month scores
measure: Mortality Risk Level
timeFrame: Change from baseline scores at the first month, second month, third month scores
measure: Severity of Fatigue
timeFrame: Change from baseline scores at the first month, second month, third month scores
Secondary outcomes:
measure: Echocardiographic Evaluation
timeFrame: Change from baseline scores at the end of third month
measure: Cardiac Enzymes of Laboratory Investigation
timeFrame: Change from baseline scores at the end of third month
measure: HbA1c of Laboratory Investigation
timeFrame: Change from baseline scores at the end of third month
measure: Body Composition
timeFrame: Change from baseline scores at the first month, second month, third month scores
Other outcomes:
Locations:
city: Nigde
country: Turkey
facility: Arzu ŞENTÜRK
Study officials:
References:
citation: Fleg JL, Cooper LS, Borlaug BA, Haykowsky MJ, Kraus WE, Levine BD, Pfeffer MA, Pina IL, Poole DC, Reeves GR, Whellan DJ, Kitzman DW; National Heart, Lung, and Blood Institute Working Group. Exercise training as therapy for heart failure: current status and future directions. Circ Heart Fail. 2015 Jan;8(1):209-20. doi: 10.1161/CIRCHEARTFAILURE.113.001420. No abstract available.
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citation: Teng HC, Yeh ML, Wang MH. Walking with controlled breathing improves exercise tolerance, anxiety, and quality of life in heart failure patients: A randomized controlled trial. Eur J Cardiovasc Nurs. 2018 Dec;17(8):717-727. doi: 10.1177/1474515118778453. Epub 2018 May 18.
citation: van Tol BA, Huijsmans RJ, Kroon DW, Schothorst M, Kwakkel G. Effects of exercise training on cardiac performance, exercise capacity and quality of life in patients with heart failure: a meta-analysis. Eur J Heart Fail. 2006 Dec;8(8):841-50. doi: 10.1016/j.ejheart.2006.02.013. Epub 2006 May 18.
citation: Nolte K, Herrmann-Lingen C, Wachter R, Gelbrich G, Dungen HD, Duvinage A, Hoischen N, von Oehsen K, Schwarz S, Hasenfuss G, Halle M, Pieske B, Edelmann F. Effects of exercise training on different quality of life dimensions in heart failure with preserved ejection fraction: the Ex-DHF-P trial. Eur J Prev Cardiol. 2015 May;22(5):582-93. doi: 10.1177/2047487314526071. Epub 2014 Mar 13.
citation: Maldonado-Martin S, Brubaker PH, Eggebeen J, Stewart KP, Kitzman DW. Association Between 6-Minute Walk Test Distance and Objective Variables of Functional Capacity After Exercise Training in Elderly Heart Failure Patients With Preserved Ejection Fraction: A Randomized Exercise Trial. Arch Phys Med Rehabil. 2017 Mar;98(3):600-603. doi: 10.1016/j.apmr.2016.08.481. Epub 2016 Sep 28.
citation: Miura Y, Fukumoto Y, Miura T, Shimada K, Asakura M, Kadokami T, Ando S, Miyata S, Sakata Y, Daida H, Matsuzaki M, Yasuda S, Kitakaze M, Shimokawa H. Impact of physical activity on cardiovascular events in patients with chronic heart failure. A multicenter prospective cohort study. Circ J. 2013;77(12):2963-72. doi: 10.1253/circj.cj-13-0746. Epub 2013 Sep 27.