Heart FailureNCT04688827
Impact of Additional Resistance Training During Rehabilitation Therapy in Patients With Heart Failure
A study testing Exercise therapy in people with Heart Failure, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of heart failure and participation in cardiac rehabilitation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Wilfried Mullens, Professor, 089 32 50 50 ext. 0032, wilfried.mullens@uhasselt.be
Kristof Gelade, Physiotherapist, 089 32 73 41 ext. 0032, kristof.gelade@zol.be
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Exercise therapy
- Keywords
- heart failure, resistance training, rehabilitation therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyOther
15 weeks of resistance training (additional to endurance training)
| Study group | Role | What they receive |
|---|---|---|
| training group 1: low-intensity resistance training | Experimental | Not described Receives: Other: Exercise therapy |
| training group 2: moderate-intensity resistance training | Experimental | Not described Receives: Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak
Maximal oxygen consumption during cardiopulmonary exercise test
Measured: Prior to the intervention
VO2peak
Maximal oxygen consumption during cardiopulmonary exercise test
Measured: After 15 weeks of intervention
VO2peak
Maximal oxygen consumption during cardiopulmonary exercise test
Measured: After 24 weeks of follow-up
Secondary outcomes (15)
Muscle strength
One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle
Measured: Prior to the intervention
Muscle strength
One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle
Measured: After 15 weeks of intervention
Muscle strength
One-repetition maximum test (1RM) to evaluate maximal contraction of the muscle
Measured: After 24 weeks of follow-up
Functional capacity
Functional capacity evaluated via the six-minute walking test
Measured: Prior to the intervention
Functional capacity
Functional capacity evaluated via the six-minute walking test
Measured: After 15 weeks of intervention
Functional capacity
Functional capacity evaluated via the six-minute walking test
Measured: After 24 weeks of follow-up
Quality of life in heart failure patients
Evaluation via Minnesota living with heart failure questionnaire
Measured: Prior to the intervention
Quality of life in heart failure patients
Evaluation via Minnesota living with heart failure questionnaire
Measured: After 15 weeks of intervention
Quality of life in heart failure patients
Evaluation via Minnesota living with heart failure questionnaire
Measured: After 24 weeks of follow-up
Cardiac function
left-ventricular ejection fraction evaluated by transthoracic echocardiography
Measured: Prior to the intervention
Cardiac function
left-ventricular ejection fraction evaluated by transthoracic echocardiography
Measured: After 15 weeks of intervention
Cardiac function
left-ventricular ejection fraction evaluated by transthoracic echocardiography
Measured: After 24 weeks of follow-up
Anthropometric measurements
body weight evaluated to determine body mass index
Measured: Prior to the intervention
Anthropometric measurements
body weight evaluated to determine body mass index
Measured: After 15 weeks of intervention
Anthropometric measurements
body weight evaluated to determine body mass index
Measured: After 24 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Aug 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688827
- Sponsor's protocol ID
- 2020044
- Status last verified
- Jul 2021
- First submitted
- 17 Dec 2020
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Types of Resistance Training Additional to Endurance Training During Rehabilitation Therapy in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT04688827
- Acronym / sponsor ID
- 2020044
- Conditions
- Heart Failure
- Keywords
- heart failure, resistance training, rehabilitation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group 1: low-intensity resistance training | Experimental | Other: Exercise therapy |
| training group 2: moderate-intensity resistance training | Experimental | Other: Exercise therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of heart failure and participation in cardiac rehabilitation
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise therapy15 weeks of resistance training (additional to endurance training) | Other | training group 1: low-intensity resistance training, training group 2: moderate-intensity resistance training |
Primary outcome
VO2peak
Time frame: Prior to the intervention
Maximal oxygen consumption during cardiopulmonary exercise test
VO2peak
Time frame: After 15 weeks of intervention
Maximal oxygen consumption during cardiopulmonary exercise test
VO2peak
Time frame: After 24 weeks of follow-up
Maximal oxygen consumption during cardiopulmonary exercise test
15 secondary outcomes
Muscle strength
Time frame: Prior to the intervention
Muscle strength
Time frame: After 15 weeks of intervention
Muscle strength
Time frame: After 24 weeks of follow-up
Functional capacity
Time frame: Prior to the intervention
Functional capacity
Time frame: After 15 weeks of intervention
Functional capacity
Time frame: After 24 weeks of follow-up
Quality of life in heart failure patients
Time frame: Prior to the intervention
Quality of life in heart failure patients
Time frame: After 15 weeks of intervention
Quality of life in heart failure patients
Time frame: After 24 weeks of follow-up
Cardiac function
Time frame: Prior to the intervention
Cardiac function
Time frame: After 15 weeks of intervention
Cardiac function
Time frame: After 24 weeks of follow-up
Anthropometric measurements
Time frame: Prior to the intervention
Anthropometric measurements
Time frame: After 15 weeks of intervention
Anthropometric measurements
Time frame: After 24 weeks of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy in people with Heart Failure, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Hansen, Professor (011 29 21 26 ext. 0032, dominique.hansen@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2peak (time frame: Prior to the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.