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

July 7, 2021 updated by: Dominique Hansen, Hasselt University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Locations

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

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: training group 1: low-intensity resistance training
15 weeks of resistance training (additional to endurance training)
Experimental: training group 2: moderate-intensity resistance training
15 weeks of resistance training (additional to endurance training)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

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 (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 28, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020044

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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