Heart FailureNCT05391620
The Effect of the 3/7 vs 3X9 Method in Resistance Training on Metabolic Stress in Cardiac Rehabilitation
A study testing Cardiac rehabilitation with 3/7 method and Cardiac rehabilitation with 3X9 method in people with Heart Failure and Resistance Training, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
The study proposes to measure the effect of resitance training (RT) (3/7 method) on biological markers of muscle hypertrophy in a cardiac population. 3/7 method consisting of five sets of an increasing number of repetitions (3 to 7) during successive sets and brief inter-set intervals (15 s). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Heart Failure, Resistance Training, Coronary Artery Disease
- What is being tested?
- Cardiac rehabilitation with 3/7 method and Cardiac rehabilitation with 3X9 method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Feb 2022to 25 Oct 2022
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Coronary artery diseases
- Heart failure with reduced ejection fraction
Who cannot join
- angina
- acutely decompensated heart failure
- electrocardiographic evidence of ischemia
- significant valvular disease
- orthopedic/neurologic disorders that limited exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of the 3/7 Method and 3X9 Method in Resistance Training on Testosterone, Glucocorticoid Cortisol, Growth Hormone and Lactate in Heart Failure and Coronary Artery Disease During Cardiac Rehabilitation
The study proposes to measure the effect of resitance training (RT) (3/7 method) on biological markers of muscle hypertrophy in a cardiac population.
3/7 method consisting of five sets of an increasing number of repetitions (3 to 7) during successive sets and brief inter-set intervals (15 s). This method is compare to 3X9 method, 3 series of 9 repetitions with inter-set (1min).The training exercise consisted of contraction on machine (leg press, triceps press, leg curl, traction, leg extension) with load of ~ 70% of one repetition maximal (1RM).
Read more
Before these trainings all subject perform HIIT on bicycles (2 min high intensity (80% Wmax) and 2 min low intensity (50% Wmax) during 30 minutes.
The investigators collect blood sample before exercice, after HIIT and after RT.
It is randomized cross-over study.
Read the detailed description
The subjects come on two different days minimum 2 days and maximum 10 days between the two tests. They were instructed to avoid exercise the day before they participated in the study.
The investigators collect blood 2 minutes after endurance training (HIIT) and 2 min after RT training.
- Conditions
- Heart Failure, Resistance Training, Coronary Artery Disease
- Being tested
- Cardiac rehabilitation with 3/7 method, Cardiac rehabilitation with 3X9 method
- Keywords
- Cardiac rehabilition, exercise therapy, metabolic stress
- Medical subject headings
- Heart Failure, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitation with 3/7 methodOther
Also called 3/7 method
HIIT ( 2 min 80% wmax: 2 min 50% wmax) during 30 minutes 3/7 method 3 rep (15 sec of rest), 4 rep (15 sec), 5 rep (15 sec), 6 rep (15 sec), 7 rep. (total volume : 25 repetitions) at 70 of 1 repetition Leg press, Dips Press, Leg curl, Traction and Leg extension.
1 minute between each machine is planned.
Cardiac rehabilitation with 3X9 methodOther
Also called 3X9 method
HIIT ( 2 min 80% wmax: 2 min 50% wmax) during 30 minutes 3X9 method 9 rep 1 minute of rest, 9 rep (1 min) and 9 rep (total volume : 27 repetitions) at 70 of 1 repetition Leg press, Dips Press, Leg curl, Traction and Leg extension.
1 minute between each machine is planned
| Study group | Role | What they receive |
|---|---|---|
| CAD group | Experimental | Coronary artery diseases Receives: Other: Cardiac rehabilitation with 3/7 method; Other: Cardiac rehabilitation with 3X9 method |
| HFrEF group | Experimental | Heart Failure with reduced Ejection Fraction Receives: Other: Cardiac rehabilitation with 3/7 method; Other: Cardiac rehabilitation with 3X9 method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lactate
mmol/l
Measured: within 2 minutes after TR training session on day 1
change in Testosterone
nmol/l
Measured: within 2 minutes after TR training session on day 1
change Glucocorticoid Cortisol
nmol/l
Measured: within 2 minutes after TR training session on day 1
change in Growth Hormone
ng/ml
Measured: within 2 minutes after TR training session on day 1
change in ph
venoust
Measured: within 2 minutes after TR training session on day 1
change PCO2 venoust
mm Hg
Measured: within 2 minutes after TR training session on day 1
Secondary outcomes (2)
Borg scale
Borg Rating of Perceived Exertion - Borg modified (0 = no exertion at all -10 maximal exertion)
Measured: within 4 minutes after TR training session on day 1
Pleasure of the session scale
0 = worse 10 = better
Measured: within 4 minutes after TR training session on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start22 Feb 2022
- Primary completion10 Jun 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis Gillet, Université Libre de Bruxelles
- Investigators
- Philippe van de borne, Professor, Study director, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391620
- Sponsor's protocol ID
- 2020276
- Status last verified
- Feb 2024
- First submitted
- 7 Apr 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: on request
Publications
Mang ZA, Realzola RA, Ducharme J, Bellissimo GF, Beam JR, Mermier C, de Castro Magalhaes F, Kravitz L, Amorim FT. The effect of repetition tempo on cardiovascular and metabolic stress when time under tension is matched during lower body exercise. Eur J Appl Physiol. 2022 Jun;122(6):1485-1495. doi: 10.1007/s00421-022-04941-3. Epub 2022 Apr 8.
PubMed 35394146
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of the 3/7 Method and 3X9 Method in Resistance Training on Testosterone, Glucocorticoid Cortisol, Growth Hormone and Lactate in Heart Failure and Coronary Artery Disease During Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT05391620
- Acronym / sponsor ID
- 2020276
- Conditions
- Heart Failure, Resistance Training, Coronary Artery Disease
- Keywords
- Cardiac rehabilition, exercise therapy, metabolic stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 26 May 2022 (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 study proposes to measure the effect of resitance training (RT) (3/7 method) on biological markers of muscle hypertrophy in a cardiac population.
3/7 method consisting of five sets of an increasing number of repetitions (3 to 7) during successive sets and brief inter-set intervals (15 s). This method is compare to 3X9 method, 3 series of 9 repetitions with inter-set (1min).The training exercise consisted of contraction on machine (leg press, triceps press, leg curl, traction, leg extension) with load of ~ 70% of one repetition maximal (1RM).
Before these trainings all subject perform HIIT on bicycles (2 min high intensity (80% Wmax) and 2 min low intensity (50% Wmax) during 30 minutes.
The investigators collect blood sample before exercice, after HIIT and after RT.
It is randomized cross-over study.
Detailed description
The subjects come on two different days minimum 2 days and maximum 10 days between the two tests. They were instructed to avoid exercise the day before they participated in the study.
The investigators collect blood 2 minutes after endurance training (HIIT) and 2 min after RT training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD group | Experimental | Other: Cardiac rehabilitation with 3/7 method, Other: Cardiac rehabilitation with 3X9 methodCoronary artery diseases |
| HFrEF group | Experimental | Other: Cardiac rehabilitation with 3/7 method, Other: Cardiac rehabilitation with 3X9 methodHeart Failure with reduced Ejection Fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical Coronary artery diseases
- Heart failure with reduced ejection fraction
Key exclusion criteria (5 listed)
- angina
- acutely decompensated heart failure
- electrocardiographic evidence of ischemia
- significant valvular disease
- orthopedic/neurologic disorders that limited exercise
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 |
|---|---|---|
| Cardiac rehabilitation with 3/7 methodAlso: 3/7 methodHIIT ( 2 min 80% wmax: 2 min 50% wmax) during 30 minutes 3/7 method 3 rep (15 sec of rest), 4 rep (15 sec), 5 rep (15 sec), 6 rep (15 sec), 7 rep. (total volume : 25 repetitions) at 70 of 1 repetition Leg press, Dips Press, Leg curl, Traction and Leg extension. 1 minute between each machine is planned. | Other | CAD group, HFrEF group |
| Cardiac rehabilitation with 3X9 methodAlso: 3X9 methodHIIT ( 2 min 80% wmax: 2 min 50% wmax) during 30 minutes 3X9 method 9 rep 1 minute of rest, 9 rep (1 min) and 9 rep (total volume : 27 repetitions) at 70 of 1 repetition Leg press, Dips Press, Leg curl, Traction and Leg extension. 1 minute between each machine is planned | Other | CAD group, HFrEF group |
Primary outcome
Change in Lactate
Time frame: within 2 minutes after TR training session on day 1
mmol/l
change in Testosterone
Time frame: within 2 minutes after TR training session on day 1
nmol/l
change Glucocorticoid Cortisol
Time frame: within 2 minutes after TR training session on day 1
nmol/l
change in Growth Hormone
Time frame: within 2 minutes after TR training session on day 1
ng/ml
change in ph
Time frame: within 2 minutes after TR training session on day 1
venoust
change PCO2 venoust
Time frame: within 2 minutes after TR training session on day 1
mm Hg
2 secondary outcomes
Borg scale
Time frame: within 4 minutes after TR training session on day 1
Pleasure of the session scale
Time frame: within 4 minutes after TR training session on day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 35394146Mang ZA, Realzola RA, Ducharme J, Bellissimo GF, Beam JR, Mermier C, de Castro Magalhaes F, Kravitz L, Amorim FT. The effect of repetition tempo on cardiovascular and metabolic stress when time under tension is matched during lower body exercise. Eur J Appl Physiol. 2022 Jun;122(6):1485-1495. doi: 10.1007/s00421-022-04941-3. Epub 2022 Apr 8.
- Individual participant dataSharing planned: No. on request
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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.
Philippe van de borne, Professor study director
Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation with 3/7 method and Cardiac rehabilitation with 3X9 method in people with Heart Failure and Resistance Training, run by Université Libre de Bruxelles 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 14 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lactate (time frame: within 2 minutes after TR training session on day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05391620, which also lists 1 linked publication.
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 14 Feb 2024.