NCT03039556

Brief Summary

This study investigates the effects of two weeks of reduced daily ambulation and a subsequent return to normal physical activity on metabolic health of older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 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

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 13, 2017

Last Update Submit

January 31, 2017

Conditions

Older AdultsReduced Physical Activity

Outcome Measures

Primary Outcomes (1)

  • Change in Insulin Sensitivity

    Assessed via Matsuda ISI

    Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)

Secondary Outcomes (3)

  • Change in lean tissue mass

    Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)

  • Change in Peak Isometric Maximal Voluntary Leg Extension Strength

    Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)

  • Change in Muscle Protein Synthesis

    Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)

Study Arms (1)

Change in physical activity for older adults

EXPERIMENTAL

Older adult participants undergo alterations in daily ambulation by completing Normal Daily Steps for one week, followed by a two-week Step-Reduction and a subsequent Return to Normal Daily Steps for two weeks

Behavioral: Normal Daily StepsBehavioral: Step-ReductionBehavioral: Return to Normal Daily Steps

Interventions

Normal Daily StepsBEHAVIORAL

Complete normal daily ambulation for one week

Change in physical activity for older adults
Step-ReductionBEHAVIORAL

Reduce daily ambulation to fewer than 1000 steps per day for two weeks

Change in physical activity for older adults
Return to Normal Daily StepsBEHAVIORAL

Increase daily ambulation to 100% of normal daily step-count for two weeks

Change in physical activity for older adults

Eligibility Criteria

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

You may qualify if:

  • Non-smoker

You may not qualify if:

  • Use of assistive walking devices
  • Chronic use of analgesic or anti-inflammatory drugs
  • History of neuromuscular problems or muscle and/or bone wasting disease
  • Acute or chronic illness including cardiac, pulmonary, liver or kidney abnormalities, uncontrolled hypertension, insulin or non-insulin dependent diabetes or other metabolic disorders
  • Daily use of statins, particularly simvastatin and atorvastatin
  • Use of medications known to affect protein metabolism
  • Normally complete fewer than 3000 steps per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (3)

  • 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

  • Devries MC, Breen L, Von Allmen M, MacDonald MJ, Moore DR, Offord EA, Horcajada MN, Breuille D, Phillips SM. Low-load resistance training during step-reduction attenuates declines in muscle mass and strength and enhances anabolic sensitivity in older men. Physiol Rep. 2015 Aug;3(8):e12493. doi: 10.14814/phy2.12493.

    PMID: 26265753BACKGROUND

  • McGlory C, von Allmen MT, Stokes T, Morton RW, Hector AJ, Lago BA, Raphenya AR, Smith BK, McArthur AG, Steinberg GR, Baker SK, Phillips SM. Failed Recovery of Glycemic Control and Myofibrillar Protein Synthesis With 2 wk of Physical Inactivity in Overweight, Prediabetic Older Adults. J Gerontol A Biol Sci Med Sci. 2018 Jul 9;73(8):1070-1077. doi: 10.1093/gerona/glx203.

    PMID: 29095970DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2017

First Posted

February 1, 2017

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

CA(1)