Impact of Additional Resistance Training During Rehabilitation Therapy in Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Exercise therapy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, resistance training, rehabilitation therapy
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
Sites / Locations
- Ziekenhuis Oost-Limburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
training group 1: low-intensity resistance training
training group 2: moderate-intensity resistance training
Arm Description
Outcomes
Primary Outcome Measures
VO2peak
Maximal oxygen consumption during cardiopulmonary exercise test
VO2peak
Maximal oxygen consumption during cardiopulmonary exercise test
VO2peak
Maximal oxygen consumption during cardiopulmonary exercise test
Secondary Outcome Measures
Muscle strength
One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle
Muscle strength
One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle
Muscle strength
One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle
Functional capacity
Functional capacity evaluated via the six-minute walking test
Functional capacity
Functional capacity evaluated via the six-minute walking test
Functional capacity
Functional capacity evaluated via the six-minute walking test
Quality of life in heart failure patients
Evaluation via Minnesota living with heart failure questionnaire
Quality of life in heart failure patients
Evaluation via Minnesota living with heart failure questionnaire
Quality of life in heart failure patients
Evaluation via Minnesota living with heart failure questionnaire
Cardiac function
left-ventricular ejection fraction evaluated by transthoracic echocardiography
Cardiac function
left-ventricular ejection fraction evaluated by transthoracic echocardiography
Cardiac function
left-ventricular ejection fraction evaluated by transthoracic echocardiography
Anthropometric measurements
body weight evaluated to determine body mass index
Anthropometric measurements
body weight evaluated to determine body mass index
Anthropometric measurements
body weight evaluated to determine body mass index
Full Information
NCT ID
NCT04688827
First Posted
December 17, 2020
Last Updated
July 7, 2021
Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
1. Study Identification
Unique Protocol Identification Number
NCT04688827
Brief Title
Impact of Additional Resistance Training During Rehabilitation Therapy in Patients With Heart Failure
Official Title
Impact of Different Types of Resistance Training Additional to Endurance Training During Rehabilitation Therapy in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, resistance training, rehabilitation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
training group 1: low-intensity resistance training
Arm Type
Experimental
Arm Title
training group 2: moderate-intensity resistance training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
15 weeks of resistance training (additional to endurance training)
Primary Outcome Measure Information:
Title
VO2peak
Description
Maximal oxygen consumption during cardiopulmonary exercise test
Time Frame
Prior to the intervention
Title
VO2peak
Description
Maximal oxygen consumption during cardiopulmonary exercise test
Time Frame
After 15 weeks of intervention
Title
VO2peak
Description
Maximal oxygen consumption during cardiopulmonary exercise test
Time Frame
After 24 weeks of follow-up
Secondary Outcome Measure Information:
Title
Muscle strength
Description
One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle
Time Frame
Prior to the intervention
Title
Muscle strength
Description
One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle
Time Frame
After 15 weeks of intervention
Title
Muscle strength
Description
One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle
Time Frame
After 24 weeks of follow-up
Title
Functional capacity
Description
Functional capacity evaluated via the six-minute walking test
Time Frame
Prior to the intervention
Title
Functional capacity
Description
Functional capacity evaluated via the six-minute walking test
Time Frame
After 15 weeks of intervention
Title
Functional capacity
Description
Functional capacity evaluated via the six-minute walking test
Time Frame
After 24 weeks of follow-up
Title
Quality of life in heart failure patients
Description
Evaluation via Minnesota living with heart failure questionnaire
Time Frame
Prior to the intervention
Title
Quality of life in heart failure patients
Description
Evaluation via Minnesota living with heart failure questionnaire
Time Frame
After 15 weeks of intervention
Title
Quality of life in heart failure patients
Description
Evaluation via Minnesota living with heart failure questionnaire
Time Frame
After 24 weeks of follow-up
Title
Cardiac function
Description
left-ventricular ejection fraction evaluated by transthoracic echocardiography
Time Frame
Prior to the intervention
Title
Cardiac function
Description
left-ventricular ejection fraction evaluated by transthoracic echocardiography
Time Frame
After 15 weeks of intervention
Title
Cardiac function
Description
left-ventricular ejection fraction evaluated by transthoracic echocardiography
Time Frame
After 24 weeks of follow-up
Title
Anthropometric measurements
Description
body weight evaluated to determine body mass index
Time Frame
Prior to the intervention
Title
Anthropometric measurements
Description
body weight evaluated to determine body mass index
Time Frame
After 15 weeks of intervention
Title
Anthropometric measurements
Description
body weight evaluated to determine body mass index
Time Frame
After 24 weeks of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Hansen, Professor
Phone
011 29 21 26
Ext
0032
Email
dominique.hansen@uhasselt.be
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilfried Mullens, Professor
Phone
089 32 50 50
Ext
0032
Email
wilfried.mullens@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Kristof Gelade, Physiotherapist
Phone
089 32 73 41
Ext
0032
Email
kristof.gelade@zol.be
12. IPD Sharing Statement
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Impact of Additional Resistance Training During Rehabilitation Therapy in Patients With Heart Failure
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