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Study of Muscle Repair Following Exercise in Young and Elderly People (MDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174692
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:

The aim of this study is to understand how healthy muscle repairs in response to eccentric exercise by evaluating functional, metabolic and molecular measures. Furthermore, this study will aim to understand the repair mechanisms in elderly healthy muscle following eccentric exercise by evaluating the same measures and highlighting age-related differences in repair mechanisms which may account for the age-related loss in muscle mass. It is hypothesised that elderly muscle will have a lesser/ blunted repair process compared to young muscle.

To meet the aims of this study and to answer the hypothesis, this study protocol is as follows:

Baseline functional, metabolic and molecular values are obtained via functional testing and a muscle biopsy. Participants then perform eccentric exercise designed to induce functional decline and muscle soreness and the contralateral leg performs concentric exercise which isn't designed to induce soreness or functional decline. Using a time-course, various metabolic and molecular measures are taken prior to and up to 7 days post exercise to understand the mechanisms underlying muscle repair. In addition the use of a novel amino acid tracer (D2O) will allow for synthesis measures over the duration of the study rather than the typical tracer techniques which only capture ~12 hours of synthesis.


Condition or disease Intervention/treatment Phase
Healthy Other: Exercise Not Applicable

Detailed Description:

Participation in this study requires participants to attend the laboratory fasted on 5 occasions spread over a period of 12 days.

Participants will report to the laboratory on the first visit for a blood sample and muscle biopsy. In order to measure muscle metabolism participants will also consume 'heavy water', which will also require participants to provide daily saliva swabs.

After 96 hours participants will be asked to arrive at the laboratory to perform a bout of heavy exercise on one leg to induce sensations of muscle soreness in the days following exercise. Investigators will then collect a blood sample and muscle biopsy from the exercised leg and do exercise tests. After this, participants will perform another bout of exercise on the other leg that will also be followed immediately by a blood sample, muscle biopsy and exercise tests. This second exercise bout is not designed to induce sensations of muscle soreness. After 5 hours , exercise tests will be performed and a further blood sample and biopsies from both legs will be collected.

Approximately, 21 hours after exercise (visit 3) participants will be asked to return to the lab for a short infusion (2.5 hour duration) of 2-deoxyglucose (2DOG), which allows investigators to measure glucose uptake. After the infusion, a blood and a muscle biopsy will be taken from each leg followed by exercising testing. Participants will then report back to the laboratory for exercise testing, a blood sample and a single muscle biopsy from both legs at 72 (visit 4) and 168 hours (visit 5) after the initial exercise session.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Exploring the Metabolic and Molecular Basis of Age-related Declines in Human Skeletal Muscle Regenerative Capacity
Study Start Date : February 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Elderly

Exercise One leg eccentric exercise: 7 sets of 10 repetitions at 80% 1 repetition maximum Contralateral leg concentric exercise: 7 sets of 10 repetitions at 80% 1 repetition maximum

2 minutes rest between sets

Other: Exercise

One leg eccentric exercise: 7 sets of 10 repetitions at 80% 1 repetition maximum Contralateral leg concentric exercise: 7 sets of 10 repetitions at 80% 1 repetition maximum

2 mins rest between sets


Experimental: Young

Exercise

One leg eccentric exercise: 7 sets of 10 repetitions at 80% 1 repetition maximum Contralateral leg concentric exercise: 7 sets of 10 repetitions at 80% 1 repetition maximum

2 minutes rest between sets

Other: Exercise

One leg eccentric exercise: 7 sets of 10 repetitions at 80% 1 repetition maximum Contralateral leg concentric exercise: 7 sets of 10 repetitions at 80% 1 repetition maximum

2 mins rest between sets





Primary Outcome Measures :
  1. Change from baseline in protein synthesis (fractional synthesis rate) in response to eccentric exercise [ Time Frame: Up to one week after exercise ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 16-30 kg/m2 BMI
  • Male
  • Sedentary
  • 18-28 years or 65-75 years

Exclusion Criteria:

  • Active cardiovascular disease
  • Cerebrovascular disease including previous stroke or aneurysm
  • Respiratory disease including pulmonary hypertension or chronic obstructive pulmonary disease
  • Metabolic disease including:

    • hyper/ hypo parathyroidism or thyroidism
    • Cushing's disease
    • Type 1 or 2 diabetes
  • Active inflammatory bowel disease
  • Renal disease
  • Malignancy
  • Recent steroid treatment (within 6 months), or hormone replacement therapy
  • Clotting dysfunction
  • Musculoskeletal or neurological disorders medication that affects muscle metabolism ie. paracetamol or non steroidal anti inflammatories (NSAID's)

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): NCT02174692


Locations
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United Kingdom
MRC-ARUK Centre of Excellence for Musculoskeletal Ageing Research, Division of Metabolic and Molecular Physiology, Postgraduate Entry Medical School, Royal Derby Hospital
Derby, Derbyshire, United Kingdom, DE22 3DT
Sponsors and Collaborators
University of Nottingham
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02174692    
Other Study ID Numbers: MDS
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015