NCT03393650

Brief Summary

Investigate the effect of 12 weeks mixed power training (power and functional exercises) combined with a protein supplementation (30g/d) or not (placebo) on physiological characteristics of muscle and functional capacities in elderly men.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

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, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

2.2 years

First QC Date

December 15, 2016

Last Update Submit

January 2, 2018

Conditions

Keywords

exerciseproteinmuscle functionaging

Outcome Measures

Primary Outcomes (1)

  • Change in walking speed

    evaluate using the 4m- normal walking speed (m/sec)

    Change from Baseline walking speed at 12 weeks measure in all subjects

Secondary Outcomes (1)

  • Change in lower limb muscle quality

    Change from Baseline lower limb muscle quality at 12 weeks measure in all subjects

Other Outcomes (1)

  • Change in mitochondrial activity

    Change from Baseline mitochondrial activity at 12 weeks measure in half of the subjects

Study Arms (2)

Exercise + Placebo group

ACTIVE COMPARATOR

50 subjects will receive a placebo supplementation with an exercise intervention (EX group)

Other: Exercise + Placebo group

Exercise + Protein group

ACTIVE COMPARATOR

50 subjects will receive a protein supplementation combined with an exercise intervention (PROTEX group)

Other: Exercise + Protein group

Interventions

1/2 of the subject will follow a mixed power training: 4 power exercises + 6 functional exercises combined to a placebo

Exercise + Placebo group

1/2 of the subject will receive 30 g/ d of protein (leucine+ vitD; divided in three equal doses: morning, afternoon and evening) + will follow a mixed power training: 4 power exercises + 6 functional exercises.

Exercise + Protein group

Eligibility Criteria

Age60 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly men
  • years and older
  • Sedentary men
  • Not obese (BMI \<30 kg/m2)
  • Living in free-living community

You may not qualify if:

  • Not able to follow an exercise program (doctor authorization: XAAP)
  • Having Lactose intolerance
  • Having Pace marker
  • Having Metabolism disorder
  • No weight stable since the last 6 months
  • No stable medication (same dose and type since at least 6 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • mylene aubertin-leheudre, PhD

    Université du Québec a Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2016

First Posted

January 8, 2018

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 8, 2018

Record last verified: 2018-01