AgingNCT04712955
Bloodflow Restricted Exercise in Healthy Ageing
A study testing Bloodflow restricted exercise in people with Aging, run by University of Aarhus at 1 site in Denmark.
Trial summary
The overall objective of this study is to investigate the efficacy of low-intensity blood flow restricted resistance exercise (BFRRE) to promote health beneficial skeletal muscle adaptations and augment muscle function in a healthy older population. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Bloodflow restricted exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Jan 2021to 1 Jul 2025
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand the written and spoken information and to give informed consent for inclusion.
- Age between 45 and 80 years
- Able to sit in a knee extension machine
- Able to deliver muscle biopsies
- Able to train 3 times per week during a 6-week period
Who cannot join
- Known history of cardiac disease
- Habitual exercise with high intensity > 2 times pr. week within the past 6 months
- Pregnancy
- Diabetes mellitus
- Peripheral neuropathy
- Dialysis treatment
Show all 12Show fewer
- Severe peripheral arterial disease
- Concomitant acute life threatening medical condition
- Intracranial aneurisms, arteriovenous malformation, cerebral neoplasm or abscess
- Severe arterial hypertension (≥ 180/≥ 110 mmHg) or moderate arterial hypertension (160-179/100-109) despite medical treatment
- Moderate or severe chronic obstructive pulmonary disease
- Decreased kidney function - eGFR < 60 ml/min
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of this study is to investigate the efficacy of low-intensity blood flow restricted resistance exercise (BFRRE) to promote health beneficial skeletal muscle adaptations and augment muscle function in a healthy older population. This objective will be achieved by in-dept evaluation of skeletal muscle cellular and functional characteristics prior to and after an intervention period comprising 6 weeks of BFRRE or non-exercise control intervention in healthy older subjects. A special focus is placed on the ability of BFRRE to stimulate skeletal muscle protein synthesis and augment muscle stem cell function.
Furthermore, recent findings suggests that similar exercise interventions in a population of patients with heart failure (HF) does not stimulate the desired adaptations. In accordance, we aim to compare the adaptive response to BFRRE amongst HF patients and the enrolled age-matched healthy individuals from the present investigation.
The findings of the current study will expand our understanding of how low-intensity resistance exercise alternatives might be viable in promoting muscle anabolism to combat the loss of muscle mass observed with ageing as well as the potential anabolic resistance accompanying HF diagnosis.
- Conditions
- Aging
- Being tested
- Bloodflow restricted exercise
- Keywords
- bloodflow restricted exercise, skeletal muscle, muscle stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bloodflow restricted exerciseOther
Also called BFRRE
Low-intensity bloodflow restricted resistance exercise is conducted as traditional knee extension exercise with a load corresponding to 30% of 1 repetition maximum (RM), with concurrent partial occlusion of the circulation by means of inflatable pneumatic cuffs wrapped around the proximal part of the thighs. Cuffs are inflated to a pressure corresponding to 50% of the arterial occlusion pressure, which only compromises venous but not arterial blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Bloodflow restricted exercise | Active comparator | Healthy subjects undergoing low intensity blood flow restricted resistance exercise (BFRRE) conducted as 4 sets of bilateral knee extensions at 30% of 1RM until voluntary fatigue. The sets are intercepted by 30 seconds of rest (during rest the cuff's are still inflated). Receives: Other: Bloodflow restricted exercise |
| Non-exercise control | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subfractional muscle protein synthesis rates
Myofibrillar protein synthesis rate
Measured: 6 weeks
Subfractional muscle protein synthesis rates
Mitochondrial protein synthesis rate
Measured: 6 weeks
Segmental muscle mass of lower extremity
Dual Energi X-ray Absorption (DEXA)
Measured: 6 weeks
Muscle fibre cross sectional area (CSA)
Histological examination of muscle biopsies
Measured: 6 weeks
Muscle stem cell function
Time to first division
Measured: 6 weeks
Muscle stem cell function
Proliferative capacity
Measured: 6 weeks
Muscle stem cell function
Differentiation capacity
Measured: 6 weeks
Secondary outcomes (3)
Maximal Voluntary Contraction (MVC)
Isometric muscle function
Measured: 6 weeks
1 repetition maximum
Dynamic muscle strength
Measured: 6 weeks
Muscle strength-endurance capacity
Local muscle endurance
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start19 Jan 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Parallel groups
- Model description
- Single center randomised controlled trial.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristian Vissing, PhD, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712955
- Sponsor's protocol ID
- 190824010610
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Groennebaek T, Jespersen NR, Jakobsgaard JE, Sieljacks P, Wang J, Rindom E, Musci RV, Botker HE, Hamilton KL, Miller BF, de Paoli FV, Vissing K. Skeletal Muscle Mitochondrial Protein Synthesis and Respiration Increase With Low-Load Blood Flow Restricted as Well as High-Load Resistance Training. Front Physiol. 2018 Dec 17;9:1796. doi: 10.3389/fphys.2018.01796. eCollection 2018.
PubMed 30618808Sieljacks P, Wang J, Groennebaek T, Rindom E, Jakobsgaard JE, Herskind J, Gravholt A, Moller AB, Musci RV, de Paoli FV, Hamilton KL, Miller BF, Vissing K. Six Weeks of Low-Load Blood Flow Restricted and High-Load Resistance Exercise Training Produce Similar Increases in Cumulative Myofibrillar Protein Synthesis and Ribosomal Biogenesis in Healthy Males. Front Physiol. 2019 May 29;10:649. doi: 10.3389/fphys.2019.00649. eCollection 2019.
PubMed 31191347Groennebaek T, Sieljacks P, Nielsen R, Pryds K, Jespersen NR, Wang J, Carlsen CR, Schmidt MR, de Paoli FV, Miller BF, Vissing K, Botker HE. Effect of Blood Flow Restricted Resistance Exercise and Remote Ischemic Conditioning on Functional Capacity and Myocellular Adaptations in Patients With Heart Failure. Circ Heart Fail. 2019 Dec;12(12):e006427. doi: 10.1161/CIRCHEARTFAILURE.119.006427. Epub 2019 Dec 13.
PubMed 31830830
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bloodflow Restricted Exercise in Healthy Ageing
- ClinicalTrials.gov ID
- NCT04712955
- Acronym / sponsor ID
- 190824010610
- Conditions
- Aging
- Keywords
- bloodflow restricted exercise, skeletal muscle, muscle stem cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 19 Jan 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 19 Jan 2021 (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 overall objective of this study is to investigate the efficacy of low-intensity blood flow restricted resistance exercise (BFRRE) to promote health beneficial skeletal muscle adaptations and augment muscle function in a healthy older population. This objective will be achieved by in-dept evaluation of skeletal muscle cellular and functional characteristics prior to and after an intervention period comprising 6 weeks of BFRRE or non-exercise control intervention in healthy older subjects. A special focus is placed on the ability of BFRRE to stimulate skeletal muscle protein synthesis and augment muscle stem cell function.
Furthermore, recent findings suggests that similar exercise interventions in a population of patients with heart failure (HF) does not stimulate the desired adaptations. In accordance, we aim to compare the adaptive response to BFRRE amongst HF patients and the enrolled age-matched healthy individuals from the present investigation.
The findings of the current study will expand our understanding of how low-intensity resistance exercise alternatives might be viable in promoting muscle anabolism to combat the loss of muscle mass observed with ageing as well as the potential anabolic resistance accompanying HF diagnosis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Bloodflow restricted exercise | Active comparator | Other: Bloodflow restricted exerciseHealthy subjects undergoing low intensity blood flow restricted resistance exercise (BFRRE) conducted as 4 sets of bilateral knee extensions at 30% of 1RM until voluntary fatigue. The sets are intercepted by 30 seconds of rest (during rest the cuff's are still inflated). |
| Non-exercise control | No intervention | –No intervention. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand the written and spoken information and to give informed consent for inclusion.
- Age between 45 and 80 years
- Able to sit in a knee extension machine
- Able to deliver muscle biopsies
- Able to train 3 times per week during a 6-week period
Key exclusion criteria (12 listed)
- Known history of cardiac disease
- Habitual exercise with high intensity > 2 times pr. week within the past 6 months
- Pregnancy
- Diabetes mellitus
- Peripheral neuropathy
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 |
|---|---|---|
| Bloodflow restricted exerciseAlso: BFRRELow-intensity bloodflow restricted resistance exercise is conducted as traditional knee extension exercise with a load corresponding to 30% of 1 repetition maximum (RM), with concurrent partial occlusion of the circulation by means of inflatable pneumatic cuffs wrapped around the proximal part of the thighs. Cuffs are inflated to a pressure corresponding to 50% of the arterial occlusion pressure, which only compromises venous but not arterial blood flow. | Other | Bloodflow restricted exercise |
Primary outcome
Subfractional muscle protein synthesis rates
Time frame: 6 weeks
Myofibrillar protein synthesis rate
Subfractional muscle protein synthesis rates
Time frame: 6 weeks
Mitochondrial protein synthesis rate
Segmental muscle mass of lower extremity
Time frame: 6 weeks
Dual Energi X-ray Absorption (DEXA)
Muscle fibre cross sectional area (CSA)
Time frame: 6 weeks
Histological examination of muscle biopsies
Muscle stem cell function
Time frame: 6 weeks
Time to first division
Muscle stem cell function
Time frame: 6 weeks
Proliferative capacity
Muscle stem cell function
Time frame: 6 weeks
Differentiation capacity
3 secondary outcomes
Maximal Voluntary Contraction (MVC)
Time frame: 6 weeks
1 repetition maximum
Time frame: 6 weeks
Muscle strength-endurance capacity
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Background: PubMed 30618808Groennebaek T, Jespersen NR, Jakobsgaard JE, Sieljacks P, Wang J, Rindom E, Musci RV, Botker HE, Hamilton KL, Miller BF, de Paoli FV, Vissing K. Skeletal Muscle Mitochondrial Protein Synthesis and Respiration Increase With Low-Load Blood Flow Restricted as Well as High-Load Resistance Training. Front Physiol. 2018 Dec 17;9:1796. doi: 10.3389/fphys.2018.01796. eCollection 2018.
- Background: PubMed 31191347Sieljacks P, Wang J, Groennebaek T, Rindom E, Jakobsgaard JE, Herskind J, Gravholt A, Moller AB, Musci RV, de Paoli FV, Hamilton KL, Miller BF, Vissing K. Six Weeks of Low-Load Blood Flow Restricted and High-Load Resistance Exercise Training Produce Similar Increases in Cumulative Myofibrillar Protein Synthesis and Ribosomal Biogenesis in Healthy Males. Front Physiol. 2019 May 29;10:649. doi: 10.3389/fphys.2019.00649. eCollection 2019.
- Background: PubMed 31830830Groennebaek T, Sieljacks P, Nielsen R, Pryds K, Jespersen NR, Wang J, Carlsen CR, Schmidt MR, de Paoli FV, Miller BF, Vissing K, Botker HE. Effect of Blood Flow Restricted Resistance Exercise and Remote Ischemic Conditioning on Functional Capacity and Myocellular Adaptations in Patients With Heart Failure. Circ Heart Fail. 2019 Dec;12(12):e006427. doi: 10.1161/CIRCHEARTFAILURE.119.006427. Epub 2019 Dec 13.
- Individual participant dataSharing planned: No
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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.
Kristian Vissing, PhD study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bloodflow restricted exercise in people with Aging, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 12 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 19 Jan 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 Denmark. 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?
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?
Subfractional muscle protein synthesis rates (time frame: 6 weeks). The study lists 7 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 NCT04712955, which also lists 3 linked publications.
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 19 Jan 2021; AzTrials last refreshed its copy on 30 Oct 2026.