NCT02495727

Brief Summary

Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength declining up to twice as fast as muscle size. This may eventually lead to loss of independence if tasks of daily living become too strenuous to be performed safely. Short periods of bed rest cause very rapid loss of muscle size and strength, and studies using healthy older participants have shown that age increases vulnerability to this muscle loss. However, it is unlikely that healthy individuals would be faced with periods of bed rest unless suffering a severe illness. In light of this, recent evidence has shown that even just reducing walking to less than 1,500 steps per day for two weeks caused 4% loss of leg muscle in over 65 year olds. This amount of activity is roughly the equivalent of being housebound, something that may become more common into older age, for example due to prolonged bad weather, or minor injury or illness. This study will investigate what causes such stark muscle loss during two weeks of reduced activity, and the impact on skeletal muscle function and size, as well as balance, body composition, and other indicators of general health such as how the body responds to food or exercise. Importantly, exercise strategies that could reduce muscle loss during a period of reduced activity will also be investigated. In brief, three groups of 10 older men (aged 65-80 years) will undertake two weeks of reduced physical activity by limiting their daily steps to \<1,500/day. All groups will then undertake a re-training exercise programme to ensure that any losses in muscle strength or size are regained. One of the groups will be a control, whereby they will undertake the step-reduction intervention and re-training, but no protective exercise before or during the step-reduction intervention. This group will allow us to achieve our primary objective of determining the influence of two weeks of reduced physical activity on muscle strength and size in healthy older males. The two other groups will undertake either four weeks of strength exercise training before the step-reduction intervention, or daily home based exercise 'snacking' during the step-reduction intervention. The potential protective benefits of the exercise interventions in reducing the impact of two weeks of reduced activity on muscle strength and size, and any effect on how muscle is re-gained afterwards, will be compared to the 'control' group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

June 25, 2015

Last Update Submit

May 21, 2018

Conditions

Keywords

Step-reduction modelReduced activityAtrophySkeletal MuscleSarcopeniaDynapenia

Outcome Measures

Primary Outcomes (1)

  • Lower limb muscle power

    Measured during leg pressing

    Two weeks- Change from baseline to post-step-reduction intervention

Secondary Outcomes (48)

  • Lower limb muscle power

    Two weeks- Change from post-step-reduction intervention to post-re-training intervention

  • Lower limb muscle power

    Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention

  • Lower limb muscle force

    Two weeks- Change from baseline to post-step-reduction intervention

  • Lower limb muscle force

    Two weeks- Change from post-step-reduction intervention to post-re-training intervention

  • Lower limb muscle force

    Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention

  • +43 more secondary outcomes

Other Outcomes (2)

  • Impact of pre-training on all primary and secondary outcomes

    Two weeks and four weeks- Change from baseline to post-step-reduction intervention, and from post-step-reduction intervention to post-retraining

  • Impact of exercise snacking on all primary and secondary outcomes

    Two weeks and four weeks- Change from baseline to post-step-reduction intervention, and from post-step-reduction intervention to post-retraining

Study Arms (3)

Control Group

EXPERIMENTAL

This group will undertake two-weeks of step-reduction to \<1,500 steps per day, followed by two-weeks of strength training exercise (6 sessions).

Behavioral: Step-reduction

Pre-Training Group

EXPERIMENTAL

This group will undertake four weeks of strength training exercise (10 sessions) before two-weeks of step-reduction to \<1,500 steps per day, followed by two-weeks of strength training exercise (6 sessions).

Behavioral: Step-reductionBehavioral: Pre-training

Exercise Snacking Group

EXPERIMENTAL

This group will undertake home-based 'exercise snacks' of simple lower limb movement (5 minutes, 3 times a day) whilst undertaking two-weeks of step-reduction to \<1,500 steps per day, followed by two-weeks of strength training exercise (6 sessions).

Behavioral: Step-reductionBehavioral: Exercise snacking

Interventions

Step-reductionBEHAVIORAL

Participants will reduce the number of steps they take each day to less than 1, 500 for two weeks, using a pedometer to monitor their daily step count.

Also known as: Reduced physical activity
Control GroupExercise Snacking GroupPre-Training Group
Pre-trainingBEHAVIORAL

Participants will attend 10 strength training exercise sessions over a four week period prior to the step-reduction intervention. These exercise sessions will be focused on lower limb strength, fully supervised and will be progressive.

Pre-Training Group

Participants will perform three bouts of five minutes of exercise each day during the two week step-reduction intervention. These will consist of five discrete exercises, each performed continuously for one minute, with one minute of rest between each exercise. These exercises will be non-supervised, and require no specialist equipment.

Exercise Snacking Group

Eligibility Criteria

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

You may qualify if:

  • Aged 65 to 80 years
  • Not underweight or obese (body mass index ≥20 and ≤ 30 kg/m2)
  • Non-smoker (for \>5 years)

You may not qualify if:

  • Any chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, peripheral arterial disease, insulin- or non-insulin dependent diabetes or other metabolic disorders - all ascertained through medical screening.
  • Individuals who consume on a daily basis any analgesic or anti-inflammatory drug(s), prescription or non-prescription will be excluded.
  • Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
  • Individuals with a history of bone, joint or neuromuscular problems or a current musculoskeletal injury ascertained through medical screening.
  • Individuals with a known bleeding disorder, on the anticoagulant drug Warfarin, or prone to keloid scarring.
  • Individuals with a known negative reaction to lidocaine anaesthetic.
  • Individuals with any joint replacement surgical implants or other artefacts containing metal.
  • Individuals who complete fewer than 3500 steps per day (as assessed by pedometer prior to the study).
  • Individuals who score less than 8 on the short physical performance battery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, Avon, BA2 7AY, United Kingdom

Location

Related Publications (2)

  • Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.

    PMID: 23589526BACKGROUND
  • Perkin OJ, Travers RL, Gonzalez JT, Turner JE, Gillison F, Wilson C, McGuigan PM, Thompson D, Stokes KA. Exercise strategies to protect against the impact of short-term reduced physical activity on muscle function and markers of health in older men: study protocol for a randomised controlled trial. Trials. 2016 Aug 2;17:381. doi: 10.1186/s13063-016-1440-z.

MeSH Terms

Conditions

Muscular AtrophyAtrophySarcopenia

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Keith Stokes, PhD

    University of Bath

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr Oliver Perkin

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 13, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

May 23, 2018

Record last verified: 2018-05

Locations