NCT02109380

Brief Summary

In the present study, the effects of 7 days of bed rest on muscle mass, muscle fiber characteristics and insulin sensitivity will be determined.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

April 1, 2014

Last Update Submit

April 27, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in quadriceps muscle cross-sectional area

    One day before and directly after cessation of bed rest.

Secondary Outcomes (5)

  • Change in lower back cross-sectional area

    One day before and directly after cessation of bed rest.

  • Change in leg and whole body lean tissue mass

    One day before and directly after cessation of bed rest.

  • Change in muscle fiber size

    One day before and directly after cessation of bed rest.

  • Change in muscle strength

    One day before and directly after cessation of bed rest.

  • Change in insulin sensitivity

    One day before and directly after cessation of bed rest.

Study Arms (1)

Bed rest

EXPERIMENTAL

One week of bed rest.

Behavioral: Bed rest

Interventions

Bed restBEHAVIORAL
Bed rest

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Aged from 18-35 years
  • \< BMI \< 30 kg/m2

You may not qualify if:

  • Smoking
  • Performing regular resistance training (3+ times per week, carrying out progressive training) in the previous 6 months
  • Hypertension (according to WHO criteria) and/or cardiovascular disease
  • Any back/leg/knee/neck/postural complaints
  • Use of any prescribed medication
  • Type 2 diabetes mellitus
  • Any family history of thrombosis
  • All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
  • Myocardial infarction within the last 3 years
  • Use of anti-coagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (2)

  • Dirks ML, Wall BT, van de Valk B, Holloway TM, Holloway GP, Chabowski A, Goossens GH, van Loon LJ. One Week of Bed Rest Leads to Substantial Muscle Atrophy and Induces Whole-Body Insulin Resistance in the Absence of Skeletal Muscle Lipid Accumulation. Diabetes. 2016 Oct;65(10):2862-75. doi: 10.2337/db15-1661. Epub 2016 Jun 29.

  • Dirks ML, Backx EM, Wall BT, Verdijk LB, van Loon LJ. May bed rest cause greater muscle loss than limb immobilization? Acta Physiol (Oxf). 2016 Sep;218(1):10-2. doi: 10.1111/apha.12699. Epub 2016 May 20. No abstract available.

MeSH Terms

Conditions

Muscular Disorders, Atrophic

Interventions

Bed Rest

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Luc JC van Loon, PhD

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 9, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations