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Trial record 41 of 621 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

Muscle Damage and Disuse Atrophy

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ClinicalTrials.gov Identifier: NCT03559452
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Francis Stephens, University of Exeter

Brief Summary:
Limb injury generally requires a period of recovery during which time the limb is often immobilised (e.g. with a cast or brace) resulting in a rapid loss of skeletal muscle. Despite the importance of muscle loss during injury, our understanding of how it occurs is incomplete. Several factors are likely to contribute, including a lack of muscle contraction and injury induced inflammation. In this study, the investigators will recruit healthy volunteers who will spend 7 days in a knee brace to replicate leg immobilisation. Prior to immobilisation, half of the participants will perform a single session of strenuous resistance exercise which is known to cause muscle damage and initiate an inflammatory response. This is designed to replicate the muscle damage and inflammation that occurs with injury. The remaining half of participants will not perform this exercise, allowing us to look at the additive effect of muscle damage and inflammation on muscle loss with immobilisation.

Condition or disease Intervention/treatment Phase
Muscle Disuse Atrophy Procedure: Eccentric exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: In Young Healthy Males and Females, What is the Effect of Prior Eccentric Exercise on Thigh Muscle Atrophy During One Week of Leg Disuse Compared to no Prior Exercise?
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Muscle damage Procedure: Eccentric exercise
300 eccentric contractions of the knee extensors




Primary Outcome Measures :
  1. Change in thigh muscle volume from pre-immobilisation [ Time Frame: After 2 days of immobilisation ]
    The volume of the muscles comprising the thigh after 2 days of immobilisation will be compared to pre-immobilisation values. This will be measured using MRI.

  2. Change in thigh muscle volume from pre-immobilisation [ Time Frame: After 7 days of immobilisation ]
    The volume of the muscles comprising the thigh after 7 days of immobilisation will be compared to pre-immobilisation values, and values obtained after 2 days of immobilisation. This will be measured using MRI.


Secondary Outcome Measures :
  1. Change in unilateral knee extensor 1 repetition maximum [ Time Frame: After 7 days of immobilisation ]
    Unilateral knee extensor 1 repetition maximum will be measured before and after 7 days of single leg immobilisation using a weight stack leg extension machine

  2. Change in unilateral knee extensor maximal voluntary torque production [ Time Frame: After 7 days of immobilisation ]
    Unilateral knee extensor maximal voluntary torque production will be measured before and after 7 days of single leg immobilisation using an isokinetic dynamometer.

  3. Change in unilateral knee extensor isokinetic total work [ Time Frame: After 7 days of immobilisation ]
    Unilateral knee extensor total isokinetic work after 30 consecutive contractions will be measured before and after 7 days of single leg immobilisation using an isokinetic dynamometer.

  4. Muscle protein synthesis assessed using the stable isotope Deuterium Oxide [ Time Frame: After 2 days of immobilisation ]
    The enrichment of deuterated alanine (from the deuterium oxide heavy water stable isotope tracer) in vastus lateralis biopsy samples will be measured relative to the non-deuterated alanine. The change between pre-immobilisation and 2 days of immobilisation will be used to calculated a fractional synthetic rate (% day).

  5. Muscle protein synthesis assessed using the stable isotope Deuterium Oxide [ Time Frame: After 7 days of immobilisation ]
    The enrichment of deuterated alanine (from the deuterium oxide heavy water stable isotope tracer) in vastus lateralis biopsy samples will be measured relative to the non-deuterated alanine. The change between pre-immobilisation and 7 days of immobilisation will be used to calculated a fractional synthetic rate (% day).

  6. Change in skeletal muscle gene expression [ Time Frame: After 2 days of immobilisation ]
    Skeletal muscle gene expression will be measured before and after 2 days of single leg immobilisation.

  7. Change in skeletal muscle gene expression [ Time Frame: After 7 days of immobilisation ]
    Skeletal muscle gene expression will be measured before and after 7 days of single leg immobilisation.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 - 40
  • BMI between 18 and 27
  • Healthy, recreationally active, non smoker

Exclusion Criteria:

  • Non-removable metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws) or claustrophobia
  • Use of nutritional supplements
  • Chronic use of over the counter medication
  • Any diagnosed metabolic disease (e.g. type 1 or 2 Diabetes).
  • Any diagnosed cardiovascular disease or hypertension.
  • Anyone with previous motor disorders. Anyone with a current musculoskeletal injury that may impair their use of crutches.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559452


Contacts
Contact: Francis Stephens +44 (0) 1392 722157 F.B.Stephens@exeter.ac.uk
Contact: Benjamin Wall +44 (0) 1392 724774 B.T.Wall@exeter.ac.uk

Locations
United Kingdom
University of Exeter Recruiting
Exeter, Devon, United Kingdom, EX1 2LU
Contact: Tom Jameson    07794865520    t.jameson@exeter.ac.uk   
Sponsors and Collaborators
University of Exeter

Responsible Party: Francis Stephens, Associate Professor, University of Exeter
ClinicalTrials.gov Identifier: NCT03559452     History of Changes
Other Study ID Numbers: 171206/B/08
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francis Stephens, University of Exeter:
Muscle damage
Inflammation
Immobilisation

Additional relevant MeSH terms:
Atrophy
Muscular Disorders, Atrophic
Pathological Conditions, Anatomical
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases