Impact of Additional Resistance Training During Rehabilitation Therapy in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
The impact of moderate- or low-intensity resistance training will be investigated additional to endurance training in heart failure patients following rehabilitation. The aim is to optimize intensity of resistance training in this patient population.

Official Title
-----------------
Impact of Different Types of Resistance Training Additional to Endurance Training During Rehabilitation Therapy in Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Exercise therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of heart failure and participation in cardiac rehabilitation Exclusion Criteria: Orthopedic disorders, neurological disorders affecting muscle strength, cognitive disorders, heart or arterial surgery (percutaneous coronary intervention, bypass, heart valve surgery) in the last year, acute myocardial infarction in the last 6 months, participation in another intervention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: training group 1: low-intensity resistance training<br> | Other: Exercise therapy<br>* 15 weeks of resistance training (additional to endurance training)<br>|
| Experimental: training group 2: moderate-intensity resistance training<br> | Other: Exercise therapy<br>* 15 weeks of resistance training (additional to endurance training)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2peak | Maximal oxygen consumption during cardiopulmonary exercise test | Prior to the intervention | 
| VO2peak | Maximal oxygen consumption during cardiopulmonary exercise test | After 15 weeks of intervention | 
| VO2peak | Maximal oxygen consumption during cardiopulmonary exercise test | After 24 weeks of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle | Prior to the intervention | 
| Muscle strength | One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle | After 15 weeks of intervention | 
| Muscle strength | One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle | After 24 weeks of follow-up | 
| Functional capacity | Functional capacity evaluated via the six-minute walking test | Prior to the intervention | 
| Functional capacity | Functional capacity evaluated via the six-minute walking test | After 15 weeks of intervention | 
| Functional capacity | Functional capacity evaluated via the six-minute walking test | After 24 weeks of follow-up | 
| Quality of life in heart failure patients | Evaluation via Minnesota living with heart failure questionnaire | Prior to the intervention | 
| Quality of life in heart failure patients | Evaluation via Minnesota living with heart failure questionnaire | After 15 weeks of intervention | 
| Quality of life in heart failure patients | Evaluation via Minnesota living with heart failure questionnaire | After 24 weeks of follow-up | 
| Cardiac function | left-ventricular ejection fraction evaluated by transthoracic echocardiography | Prior to the intervention | 
| Cardiac function | left-ventricular ejection fraction evaluated by transthoracic echocardiography | After 15 weeks of intervention | 
| Cardiac function | left-ventricular ejection fraction evaluated by transthoracic echocardiography | After 24 weeks of follow-up | 
| Anthropometric measurements | body weight evaluated to determine body mass index | Prior to the intervention | 
| Anthropometric measurements | body weight evaluated to determine body mass index | After 15 weeks of intervention | 
| Anthropometric measurements | body weight evaluated to determine body mass index | After 24 weeks of follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, resistance training, rehabilitation therapy