Bloodflow Restricted Exercise in Healthy Ageing
1 other identifier
interventional
24
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 19, 2021
CompletedStudy Start
First participant enrolled
January 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJanuary 19, 2021
January 1, 2021
10 months
January 8, 2021
January 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Subfractional muscle protein synthesis rates
Myofibrillar protein synthesis rate
6 weeks
Subfractional muscle protein synthesis rates
Mitochondrial protein synthesis rate
6 weeks
Segmental muscle mass of lower extremity
Dual Energi X-ray Absorption (DEXA)
6 weeks
Muscle fibre cross sectional area (CSA)
Histological examination of muscle biopsies
6 weeks
Muscle stem cell function
Time to first division
6 weeks
Muscle stem cell function
Proliferative capacity
6 weeks
Muscle stem cell function
Differentiation capacity
6 weeks
Secondary Outcomes (3)
Maximal Voluntary Contraction (MVC)
6 weeks
1 repetition maximum
6 weeks
Muscle strength-endurance capacity
6 weeks
Study Arms (2)
Bloodflow restricted exercise
ACTIVE COMPARATORHealthy 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 INTERVENTIONNo intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Aarhus
Aarhus, 8000, Denmark
Related Publications (3)
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.
PMID: 30618808BACKGROUNDSieljacks 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.
PMID: 31191347BACKGROUNDGroennebaek 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.
PMID: 31830830BACKGROUND
Study Officials
- STUDY DIRECTOR
Kristian Vissing, PhD
University of Aarhus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2021
First Posted
January 19, 2021
Study Start
January 19, 2021
Primary Completion
November 1, 2021
Study Completion
July 1, 2025
Last Updated
January 19, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share