Clinical trial NCT04712955: Bloodflow Restricted Exercise in Healthy Ageing
Official title: Bloodflow Restricted Exercise in Healthy Ageing
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Aging
Keywords: bloodflow restricted exercise
skeletal muscle
muscle stem cells
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center randomised controlled trial.
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Subfractional muscle protein synthesis rates
timeFrame: 6 weeks
measure: Subfractional muscle protein synthesis rates
timeFrame: 6 weeks
measure: Segmental muscle mass of lower extremity
timeFrame: 6 weeks
measure: Muscle fibre cross sectional area (CSA)
timeFrame: 6 weeks
measure: Muscle stem cell function
timeFrame: 6 weeks
measure: Muscle stem cell function
timeFrame: 6 weeks
measure: Muscle stem cell function
timeFrame: 6 weeks
Secondary outcomes:
measure: Maximal Voluntary Contraction (MVC)
timeFrame: 6 weeks
measure: 1 repetition maximum
timeFrame: 6 weeks
measure: Muscle strength-endurance capacity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: University of Aarhus
Study officials:
affiliation: University of Aarhus
name: Kristian Vissing, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Sieljacks 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.
citation: Groennebaek 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.