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Clinical Trials/NCT05349786
NCT05349786
Completed
N/A

The Effect of the Physical Activity Program on Quality of Life, Functional Capacity and Mortality Risk Level in Individuals With Heart Failure

Nigde Omer Halisdemir University1 site in 1 country40 target enrollmentJune 11, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Nigde Omer Halisdemir University
Enrollment
40
Locations
1
Primary Endpoint
Severity of Fatigue
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2018
End Date
July 16, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nigde Omer Halisdemir University
Responsible Party
Principal Investigator
Principal Investigator

Arzu Senturk

Principal Investigator, Research Assistant (RN, MSN, PhD)

Nigde Omer Halisdemir University

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

Outcomes

Primary Outcomes

Severity of Fatigue

Time Frame: Change from baseline scores at the first month, second month, third month scores

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.

Quality of Life Level

Time Frame: Change from baseline scores at the first month, second month, third month scores

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.

Functional Capacity Level

Time Frame: Change from baseline scores at the first month, second month, third month scores

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.

Mortality Risk Level

Time Frame: Change from baseline scores at the first month, second month, third month scores

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.

Secondary Outcomes

  • Body Composition(Change from baseline scores at the first month, second month, third month scores)
  • Cardiac Enzymes of Laboratory Investigation(Change from baseline scores at the end of third month)
  • Echocardiographic Evaluation(Change from baseline scores at the end of third month)
  • HbA1c of Laboratory Investigation(Change from baseline scores at the end of third month)

Study Sites (1)

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