Bloodflow Restricted Exercise in Healthy Ageing

Aging Clinical Trial

Official title:

Bloodflow Restricted Exercise in Healthy Ageing

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04712955
• Other study ID #: 190824010610
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: July 1, 2025
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• Bloodflow restricted exercise
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.

Locations

Country	Name	City	State
Denmark	University of Aarhus	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Groennebaek T, Jespersen NR, Jakobsgaard JE, Sieljacks P, Wang J, Rindom E, Musci RV, Bøtker 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. — View Citation

Groennebaek T, Sieljacks P, Nielsen R, Pryds K, Jespersen NR, Wang J, Carlsen CR, Schmidt MR, de Paoli FV, Miller BF, Vissing K, Bøtker 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. — View Citation

Sieljacks P, Wang J, Groennebaek T, Rindom E, Jakobsgaard JE, Herskind J, Gravholt A, Møller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subfractional muscle protein synthesis rates	Myofibrillar protein synthesis rate	6 weeks
Primary	Subfractional muscle protein synthesis rates	Mitochondrial protein synthesis rate	6 weeks
Primary	Segmental muscle mass of lower extremity	Dual Energi X-ray Absorption (DEXA)	6 weeks
Primary	Muscle fibre cross sectional area (CSA)	Histological examination of muscle biopsies	6 weeks
Primary	Muscle stem cell function	Time to first division	6 weeks
Primary	Muscle stem cell function	Proliferative capacity	6 weeks
Primary	Muscle stem cell function	Differentiation capacity	6 weeks
Secondary	Maximal Voluntary Contraction (MVC)	Isometric muscle function	6 weeks
Secondary	1 repetition maximum	Dynamic muscle strength	6 weeks
Secondary	Muscle strength-endurance capacity	Local muscle endurance	6 weeks