Back to resultsPhysical Activity Program on Clinical Output in Heart Failure (Heartfailu)
Primary Purpose
Heart Failure, Nursing Caries
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physical activity program
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Heart failure, Physical activity, Functional capacity, Quality of life, NT-proBNP, Mortality risk level
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
Sites / Locations
- Arzu ŞENTÜRK
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Non-Intervention Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Echocardiographic Evaluation
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.
Cardiac Enzymes of Laboratory Investigation
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.
HbA1c of Laboratory Investigation
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.
Body Composition
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.
Full Information
NCT ID
NCT05349786
First Posted
April 16, 2022
Last Updated
April 22, 2022
Sponsor
Nigde Omer Halisdemir University
1. Study Identification
Unique Protocol Identification Number
NCT05349786
Brief Title
Physical Activity Program on Clinical Output in Heart Failure
Acronym
Heartfailu
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
December 3, 2018 (Actual)
Study Completion Date
July 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nigde Omer Halisdemir University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Nursing Caries
Keywords
Heart failure, Physical activity, Functional capacity, Quality of life, NT-proBNP, Mortality risk level
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Intervention Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical activity program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life Level
Description
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.
Time Frame
Change from baseline scores at the first month, second month, third month scores
Title
Functional Capacity Level
Description
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.
Time Frame
Change from baseline scores at the first month, second month, third month scores
Title
Mortality Risk Level
Description
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.
Time Frame
Change from baseline scores at the first month, second month, third month scores
Title
Severity of Fatigue
Description
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.
Time Frame
Change from baseline scores at the first month, second month, third month scores
Secondary Outcome Measure Information:
Title
Echocardiographic Evaluation
Description
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.
Time Frame
Change from baseline scores at the end of third month
Title
Cardiac Enzymes of Laboratory Investigation
Description
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.
Time Frame
Change from baseline scores at the end of third month
Title
HbA1c of Laboratory Investigation
Description
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.
Time Frame
Change from baseline scores at the end of third month
Title
Body Composition
Description
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.
Time Frame
Change from baseline scores at the first month, second month, third month scores
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Arzu ŞENTÜRK
City
Nigde
ZIP/Postal Code
51200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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Citation
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Physical Activity Program on Clinical Output in Heart Failure
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