NCT Number: NCT02571270
12-Week-Combined Physical Training In Heart Failure Patients
Purpose: Physical exercise exerts favorable impact on functional capacity (FC) and quality of life (QL) in patients with heart failure (HF). It is believed that the combined aerobic and resistance physical training (CPT) supervised by physical educator is better than only prescription of unsupervised exercise. The aim of this study is to compare the effects of a CPT program on the FC and QL of HF patients with reduced ejection fraction (HFREF) with the practice medical routine prescription of regular physical activity and correlate these findings with clinical and echocardiographic variables.
Methods: A longitudinal prospective study included 28 consecutive HFREF patients randomly divided in two age- and gender- matched groups: Trained Group (TG, n = 17), patients undergoing 12 weeks of supervised CPT and Non Trained Group (NTG, n = 11), patients receiving only medical prescription to practice regular physical exercise. All patients were submitted to clinical evaluation, transthoracic echocardiography, Cooper walk test and QL questionnaire before and after the study protocol. Student t test or Mann-Whitney test were performed for groups comparison and correlation tests for the same group variable associations.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with heart failure with LVEF <50%;
- Patients with optimized drug therapy;
- Age over 18 years.
Exclusion criteria
- Heart failure NYHA class IV and/or Stage D;
- Decompensated HF in the last three months;
- Atrial fibrillation and/or implantable device at the moment of inclusion;
- Patients with chronic obstructive pulmonary disease (COPD);
- Patients with biomechanical limitations of physical activity.
Treatment and study plan
Primary outcomes
-
Questionnaire about quality of life
Time frame: up to 12 weeks of research
-
Cardiorespiratory evaluation (VO2 in Mets)
Time frame: up to 12 weeks of research
-
Morphological echocardiographic variables (mm)
Time frame: up to 12 weeks of research
-
Sistolic Function echocardiographic variables (Percentage)
Time frame: up to 12 weeks of research
-
Diastolic Function echocardiographic variables (cm/s)
Time frame: up to 12 weeks of research
Secondary outcomes
-
Anthropometric measurements (cm)
Time frame: up to 12 weeks of research
-
Body composition (%fat percentage)
Time frame: up to 12 weeks of research
-
Presence of comorbidities
Time frame: up to 12 weeks of research
-
Blood pressure measurement (mmHg)
Time frame: up to 12 weeks of research
Sponsors and collaborators
Lead sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Other
Registry information
Official study title
Impact Of Supervised 12-Week-Combined Physical Training In Heart Failure Patients: A Randomized Trial
Important dates
- Study start
- 2015
- Primary completion
- 2015
- First posted
- Oct 8, 2015
- Registry last updated
- Oct 8, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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