NCT04641117

Brief Summary

Participants will be 60-80 y men and women who vary their physical activity (steps/day) while their lipid metabolism is studied (n=24). Thereafter, another group (n=60) will perform 6 months of exercise training focused on developing maximal cycling power, during which their changes in muscle mass and practical function will be carefully measured.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress90%
Jan 2021Dec 2026

First Submitted

Initial submission to the registry

November 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

5 years

First QC Date

November 17, 2020

Last Update Submit

November 17, 2020

Conditions

Exercise Training and Sarcopenia

Outcome Measures

Primary Outcomes (2)

  • Muscle mass

    MRI determined changes in thigh muscle volume

    six months

  • Post-prandial lipemia

    The elevation of plasma triglycerides after a meal

    one month

Study Arms (1)

Exercise

EXPERIMENTAL

Six months of power training

Other: Exercise

Interventions

ExerciseOTHER

Walking and Power Training

Exercise

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • relatively healthy

You may not qualify if:

  • relatively unhealthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin Human Performance Laboratory

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Subjects will power train
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 23, 2020

Study Start

January 1, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

November 23, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)