- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04688827
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
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
- Name: Dominique Hansen, Professor
- Phone Number: 0032 011 29 21 26
- Email: dominique.hansen@uhasselt.be
Study Locations
-
-
Limburg
-
Genk, Limburg, Belgium, 3600
- Ziekenhuis Oost-Limburg
-
Contact:
- Wilfried Mullens, Professor
- Phone Number: 0032 089 32 50 50
- Email: wilfried.mullens@uhasselt.be
-
Contact:
- Kristof Gelade, Physiotherapist
- Phone Number: 0032 089 32 73 41
- Email: kristof.gelade@zol.be
-
-
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.
Sponsor
Collaborators
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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