Physical Activity Program on Clinical Output in Heart Failure

NCT05349786 | Completed DMC

• 1 other identifier: NOHU- Cardiac Nursing
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Nursing Caries

Keywords

Heart failure; Physical activity; Functional capacity; Quality of life; NT-proBNP; Mortality risk level

Outcome Measures

Primary Outcomes (4)

• Quality of Life Level

  Quality of life level were evaluated with the Minnesota Living with Heart Failure Questionnaire. Minnesota Living with Heart Failure Questionnaire was developed by Rector et al. to measure the quality of life in patients with heart failure. The total score of the scale, which has two sub-dimensions as "physical function" and "emotional", varies between 0 and 105. A low score indicates good quality of life, and a high score indicates poor quality of life.

  Change from baseline scores at the first month, second month, third month scores

• Functional Capacity Level

  Functional capacity level was evaluated with the International Physical Activity Questionnaire-Short Form and 6-Min Walking Test. International Physical Activity Questionnaire- Short Form developed by Craig et al. evaluates the duration of physical activity in the last seven days and the time spent sitting per day without moving. The energy required for each activity in the IPAQ is calculated with the metabolic equivalent-minute score according to the activity type or intensity. Functional capacity was evaluated with 6MWT according to the criteria of the "American Thoracic Society" guideline and the 6MWT distance reached at the end of the test was recorded in meters (m). In the study, the blood pressure of individuals was measured before and after 6MWT. Oxygen saturation and heart rate measurements were made and recorded with a portable pulse oximeter.

  Change from baseline scores at the first month, second month, third month scores

• Mortality Risk Level

  Mortality risk level was evaluated with Meta-Analysis Global Group in Chronic Heart Failure scores. To predict one- and three-year mortality in HF, with MAGGIC, Pocock et al. (2013) analyzed 30 cohort studies with a large number of patients, and they developed a risk scoring database based on HF risk factors. MAGGIC risk scoring results, provides a preliminary assessment in determining the one-year mortality in HF patients. In our study, the MAGGIC scores, which were obtained by taking the scores related to the initial and final follow-up, were compared. NT-proBNP serum concentration measurements, especially ventricular ischemic injury, have an important place in the prediction of mortality. In our study, serum NT-proBNP level was investigated to determine the diagnosis and prognosis of HF, to determine the functional capacity and the relationship between MAGGIC risk scoring and mortality risk.

  Change from baseline scores at the first month, second month, third month scores

• Severity of Fatigue

  Fatigue Severity Scale used to evaluate the severity of fatigue in the last month was developed by Krupp in 1989. The low total score of the scale with a cut-off value of 4 and above for pathological fatigue indicates low fatigue.

  Change from baseline scores at the first month, second month, third month scores

Secondary Outcomes (4)

• Echocardiographic Evaluation

  Change from baseline scores at the end of third month

• Cardiac Enzymes of Laboratory Investigation

  Change from baseline scores at the end of third month

• HbA1c of Laboratory Investigation

  Change from baseline scores at the end of third month

• Body Composition

  Change from baseline scores at the first month, second month, third month scores

Study Arms (2)

Intervention Group

EXPERIMENTAL

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. A pedometer was used to visualize the walking performed in the physical activity program and to record reliably. Weekly phone calls and monthly home visits were made to the patients in order to determine the continuation of the medical treatment and walking program used by the patients, to increase their motivation and to detect or intervene in any situation related to the walking program.

Other: Physical activity program

Non-Intervention Group

NO INTERVENTION

The individuals in the control group, were pre-tested, evaluated at the first, second, and third months, and followed up in the process without any intervention. Patients were reminded that they should continue their routine medical treatment and not start any physical activity program.

Interventions

Physical activity program OTHER

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. A pedometer was used to visualize the walking performed in the physical activity program and to record reliably. After the data obtained in the pre-test, the pedometers, which were calibrated and checked by the researchers, were delivered to the patients. At the end of each day of walking with pedometer monitoring, they were asked to record data such as the number of steps, walking hour, walking time, distance and complaints encountered during walking on the walking monitoring chart given to the patient by the researchers. Weekly phone calls and monthly home visits were made to the patients in order to determine the continuation of the medical treatment and walking program used by the patients, to increase their motivation and to detect or intervene in any situation related to the walking program.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Arzu ŞENTÜRK

Niğde, 51200, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 25605639 BACKGROUND

• Hassanpour Dehkordi A, Khaledi Far A. Effect of exercise training on the quality of life and echocardiography parameter of systolic function in patients with chronic heart failure: a randomized trial. Asian J Sports Med. 2015 Mar;6(1):e22643. doi: 10.5812/asjsm.22643. Epub 2015 Mar 20.

  PMID: 25883771 BACKGROUND

• Vetrovsky T, Siranec M, Parenica J, Griva M, Stastny J, Precek J, Pelouch R, Bunc V, Linhart A, Belohlavek J. Effect of a 6-month pedometer-based walking intervention on functional capacity in patients with chronic heart failure with reduced (HFrEF) and with preserved (HFpEF) ejection fraction: study protocol for two multicenter randomized controlled trials. J Transl Med. 2017 Jul 3;15(1):153. doi: 10.1186/s12967-017-1257-x.

  PMID: 28673328 BACKGROUND

• 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.

  PMID: 29775076 BACKGROUND

• 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.

  PMID: 16713337 BACKGROUND

• 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.

  PMID: 24627449 BACKGROUND

• 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.

  PMID: 27693420 BACKGROUND

• 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.

  PMID: 24077060 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Assistant (RN, MSN, PhD)

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 27, 2022
• Study Start: June 11, 2018
• Primary Completion: December 3, 2018
• Study Completion: July 16, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)