NCT02174692

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

2.1 years

First QC Date

June 11, 2014

Last Update Submit

May 28, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in protein synthesis (fractional synthesis rate) in response to eccentric exercise

    Up to one week after exercise

Study Arms (2)

Elderly

EXPERIMENTAL

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

Young

EXPERIMENTAL

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

Interventions

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

ElderlyYoung

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • kg/m2 BMI
  • Male
  • Sedentary
  • years or 65-75 years

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRC-ARUK Centre of Excellence for Musculoskeletal Ageing Research, Division of Metabolic and Molecular Physiology, Postgraduate Entry Medical School, Royal Derby Hospital

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 25, 2014

Study Start

February 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations