NCT04422665

Brief Summary

Episodes of inactivity due to hospitalisation, as short as 5 days, are associated with rapid muscle and strength loss in the elderly. The observed muscle loss with inactivity is likely due to muscle anabolic resistance and increased breakdown rates of muscle tissue. This is of great concern as the average hospital stay in the elderly is 5-6 days. Moreover, minor illnesses not requiring hospitalisation generally require short-term periods of inactive home-based recovery. The accumulation of repeated disuse events in older individuals manifests in a chronic muscle anabolic resistance (i.e. the inability of muscle to respond to anabolic stimuli such as exercise and nutrition) that may underpin the slow but devastating process of age-related muscle loss. It is our belief that strategies to promote muscle health in ageing and reduce healthcare expenditure, should focus on alleviating muscle deterioration and anabolic resistance during short-term disuse. In this regard, we propose that resistance exercise (i.e. weight lifting) performed prior to a disuse event (termed 'prehabilitation') may be sufficient to offset muscle loss in older individuals. Thus, we suggest the potent effect of resistance exercise in older muscles may prevent muscle loss during short-term disuse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

June 9, 2020

Status Verified

January 1, 2020

Enrollment Period

2.1 years

First QC Date

June 1, 2020

Last Update Submit

June 4, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Integrated myofibrillar protein synthesis rates

    Myofibrillar protein synthesis rates will be measured during the prehabilitation and bed rest period in both the exercising and resting leg.

    2 years

  • Muscle mass via MRI

    Muscle volume in the quadriceps will be assessed before and after bed rest using magnetic resonance imaging techniques

    2 years

Secondary Outcomes (13)

  • Muscle fibre properties

    2 years

  • Physical activity levels

    2 years

  • Step-count

    2 years

  • Plasma biomarkers of metabolic health

    2 years

  • Serum insulin

    2 years

  • +8 more secondary outcomes

Study Arms (2)

Single Exercise

EXPERIMENTAL

Subjects allocated to this group will perform a single bout of one-legged resistance exercise. This bout will take place 1 day prior to the start of the bed rest. The resistance exercise will consist of 8 sets of leg extensions and 8 sets of leg curls. The non-exercising leg will serve as an internal control. The dominant leg will perform the exercise.

Other: Resistance exercise

Multi Exercise

EXPERIMENTAL

Subjects allocated to this group will perform 4 bouts of one-legged resistance exercise. These bouts will take place on alternate days the week leading up to the bed rest. Each resistance exercise bout will consist of 8 sets of leg extensions and 8 sets of leg curls. The non-exercising leg will serve as an internal control. The dominant leg will perform the exercise.

Other: Resistance exercise

Interventions

Single-legged resistance exercise

Multi ExerciseSingle Exercise

Eligibility Criteria

Age65 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Males aged between 65-80 years
  • No history of structured resistance training within 10 years prior to study participation.
  • Generally good health as indicated by a thorough health questionnaire.
  • A score of ≥9 points on the Short Physical Performance Battery to assess lower extremity function.
  • Body Mass Index \<30kg/m2

You may not qualify if:

  • Coagulation disorders
  • Myocardial infarction
  • Artery/vein disease
  • Hormone replacement therapy
  • Other chronic/systemic illnesses (i.e. renal failure, chronic obstructive pulmonary disease, cancer).
  • Undergone 2 or more muscle biopsies from each leg previously.
  • Received a stable isotope infusion in the last 3 years prior to study enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences

Edgbaston, West Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Muscular AtrophyMuscular Disorders, AtrophicSarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated to one of two intervention groups. Due to the single-legged typed of resistance exercise, each subject will be its own control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 9, 2020

Study Start

September 1, 2017

Primary Completion

October 1, 2019

Study Completion

January 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations