NCT04712955

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 19, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

January 8, 2021

Last Update Submit

January 14, 2021

Conditions

Keywords

bloodflow restricted exerciseskeletal musclemuscle stem cells

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 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).

Other: Bloodflow restricted exercise

Non-exercise control

NO INTERVENTION

No 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.

Also known as: BFRRE
Bloodflow restricted exercise

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 30618808BACKGROUND
  • 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.

    PMID: 31191347BACKGROUND
  • 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.

    PMID: 31830830BACKGROUND

Study Officials

  • Kristian Vissing, PhD

    University of Aarhus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Single center randomised controlled trial.
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

Locations