Physical Activity Program on Clinical Output in Heart Failure (Heartfailu)

April 22, 2022 updated by: Arzu Senturk, Nigde Omer Halisdemir University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Nigde, Turkey, 51200
        • Arzu ŞENTÜRK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
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.
No Intervention: Non-Intervention Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline scores at the first month, second month, third month scores
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.
Change from baseline scores at the first month, second month, third month scores
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.
Change from baseline scores at the first month, second month, third month scores
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.
Change from baseline scores at the first month, second month, third month scores

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiographic Evaluation
Time Frame: Change from baseline scores at the end of third month
There is a LVEF finding as an Echo finding made by the physician to be used in the MAGGIC scoring calculation. Considering that Echo evaluation may vary according to the physician's follow-up, it was ensured that the EF levels of the individuals were performed by the operator who performed the initial follow-up.
Change from baseline scores at the end of third month
Cardiac Enzymes of Laboratory Investigation
Time Frame: Change from baseline scores at the end of third month
The biochemical variables that may accompany the cause and functional classification of HF were taken from the file information. Among the biochemical values, cardiac enzymes troponin and LDH and NT-proBNP levels were examined.
Change from baseline scores at the end of third month
HbA1c of Laboratory Investigation
Time Frame: Change from baseline scores at the end of third month
The HbA1c within biochemical variables that may accompany the cause and functional classification of HF were taken from the file information. Among the biochemical values, HbA1c levels were investigated in order to evaluate the regulated status of individuals with diabetes mellitus and the effect of physical activity program.
Change from baseline scores at the end of third month
Body Composition
Time Frame: Change from baseline scores at the first month, second month, third month scores
In order to evaluate the effect of the physical activity program on the body analysis results, measurement parameter data and body mass index composition (BMI in kg/m^2) (e.g. body weight, body mass index, body fat rate, body muscle mass, body water rate, basal metabolic rate) were obtained from the individuals using a body analysis scale.
Change from baseline scores at the first month, second month, third month scores

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2018

Primary Completion (Actual)

December 3, 2018

Study Completion (Actual)

July 16, 2021

Study Registration Dates

First Submitted

April 16, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOHU- Cardiac Nursing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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