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

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ClinicalTrials.gov Identifier: NCT04688827
Recruitment Status : Not yet recruiting
First Posted : December 30, 2020
Last Update Posted : July 8, 2021
Sponsor:
Collaborator:
Ziekenhuis Oost-Limburg
Information provided by (Responsible Party):
Dominique Hansen, Hasselt University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Exercise therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Different Types of Resistance Training Additional to Endurance Training During Rehabilitation Therapy in Patients With Heart Failure
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: training group 1: low-intensity resistance training Other: Exercise therapy
15 weeks of resistance training (additional to endurance training)
Experimental: training group 2: moderate-intensity resistance training Other: Exercise therapy
15 weeks of resistance training (additional to endurance training)


Outcome Measures
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Primary Outcome Measures :
  1. VO2peak [ Time Frame: Prior to the intervention ]
    Maximal oxygen consumption during cardiopulmonary exercise test

  2. VO2peak [ Time Frame: After 15 weeks of intervention ]
    Maximal oxygen consumption during cardiopulmonary exercise test

  3. VO2peak [ Time Frame: After 24 weeks of follow-up ]
    Maximal oxygen consumption during cardiopulmonary exercise test


Secondary Outcome Measures :
  1. Muscle strength [ Time Frame: Prior to the intervention ]
    One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle

  2. Muscle strength [ Time Frame: After 15 weeks of intervention ]
    One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle

  3. Muscle strength [ Time Frame: After 24 weeks of follow-up ]
    One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle

  4. Functional capacity [ Time Frame: Prior to the intervention ]
    Functional capacity evaluated via the six-minute walking test

  5. Functional capacity [ Time Frame: After 15 weeks of intervention ]
    Functional capacity evaluated via the six-minute walking test

  6. Functional capacity [ Time Frame: After 24 weeks of follow-up ]
    Functional capacity evaluated via the six-minute walking test

  7. Quality of life in heart failure patients [ Time Frame: Prior to the intervention ]
    Evaluation via Minnesota living with heart failure questionnaire

  8. Quality of life in heart failure patients [ Time Frame: After 15 weeks of intervention ]
    Evaluation via Minnesota living with heart failure questionnaire

  9. Quality of life in heart failure patients [ Time Frame: After 24 weeks of follow-up ]
    Evaluation via Minnesota living with heart failure questionnaire

  10. Cardiac function [ Time Frame: Prior to the intervention ]
    left-ventricular ejection fraction evaluated by transthoracic echocardiography

  11. Cardiac function [ Time Frame: After 15 weeks of intervention ]
    left-ventricular ejection fraction evaluated by transthoracic echocardiography

  12. Cardiac function [ Time Frame: After 24 weeks of follow-up ]
    left-ventricular ejection fraction evaluated by transthoracic echocardiography

  13. Anthropometric measurements [ Time Frame: Prior to the intervention ]
    body weight evaluated to determine body mass index

  14. Anthropometric measurements [ Time Frame: After 15 weeks of intervention ]
    body weight evaluated to determine body mass index

  15. Anthropometric measurements [ Time Frame: After 24 weeks of follow-up ]
    body weight evaluated to determine body mass index


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688827


Contacts
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Contact: Dominique Hansen, Professor 011 29 21 26 ext 0032 dominique.hansen@uhasselt.be

Locations
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Belgium
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
Contact: Wilfried Mullens, Professor    089 32 50 50 ext 0032    wilfried.mullens@uhasselt.be   
Contact: Kristof Gelade, Physiotherapist    089 32 73 41 ext 0032    kristof.gelade@zol.be   
Sponsors and Collaborators
Hasselt University
Ziekenhuis Oost-Limburg
More Information
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Responsible Party: Dominique Hansen, Professor, Hasselt University
ClinicalTrials.gov Identifier: NCT04688827    
Other Study ID Numbers: 2020044
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dominique Hansen, Hasselt University:
heart failure
resistance training
rehabilitation therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases