Bloodflow Restricted Exercise in Healthy Ageing

January 14, 2021 updated by: University of Aarhus

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • University of Aarhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bloodflow restricted exercise
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).
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.
Other Names:
  • BFRRE
NO_INTERVENTION: Non-exercise control
No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subfractional muscle protein synthesis rates
Time Frame: 6 weeks
Myofibrillar protein synthesis rate
6 weeks
Subfractional muscle protein synthesis rates
Time Frame: 6 weeks
Mitochondrial protein synthesis rate
6 weeks
Segmental muscle mass of lower extremity
Time Frame: 6 weeks
Dual Energi X-ray Absorption (DEXA)
6 weeks
Muscle fibre cross sectional area (CSA)
Time Frame: 6 weeks
Histological examination of muscle biopsies
6 weeks
Muscle stem cell function
Time Frame: 6 weeks
Time to first division
6 weeks
Muscle stem cell function
Time Frame: 6 weeks
Proliferative capacity
6 weeks
Muscle stem cell function
Time Frame: 6 weeks
Differentiation capacity
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Voluntary Contraction (MVC)
Time Frame: 6 weeks
Isometric muscle function
6 weeks
1 repetition maximum
Time Frame: 6 weeks
Dynamic muscle strength
6 weeks
Muscle strength-endurance capacity
Time Frame: 6 weeks
Local muscle endurance
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Kristian Vissing, PhD, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 19, 2021

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

July 1, 2025

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (ACTUAL)

January 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 190824010610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on Bloodflow restricted exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe