NCT01722136

Brief Summary

The overall goal is to determine whether any energy expenditure compensation in response to 16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose intervention in older women, and to begin to investigate underlying physiological mechanisms that influence energy expenditure changes in older women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

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

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 6, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 19, 2019

Status Verified

May 1, 2016

Enrollment Period

2.8 years

First QC Date

October 24, 2012

Last Update Submit

April 17, 2019

Conditions

Condition

Outcome Measures

Primary Outcomes (1)

  • Change from baseline total daily energy expenditure and its components (resting metabolic rate, thermic effect of food, non-exercise activity thermogenesis)in 4 months

    Baseline (pre-intervention); 4 months (post-intervention)

Secondary Outcomes (1)

  • Change from baseline plasma leptin and serum free triiodo-L-thyronine (free T3) concentrations in 4 months

    Baseline (pre-intervention); 4 month (post-intervention)

Study Arms (2)

Low Dosage

EXPERIMENTAL

Exercise dose of 8kcal/kg/week

Behavioral: Low Dosage

High Dosage

EXPERIMENTAL

Exercise dose 14kcal/kg/week

Behavioral: High Dosage

Interventions

Low DosageBEHAVIORAL

Exercise dose of 8kcal/kg/week

Low Dosage
High DosageBEHAVIORAL

Exercise dose of 14kcal/kg/week

High Dosage

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18-30
  • Sedentary (exercising less than 20 minutes no more than 3 times per week)
  • Non-smoking
  • Weight stable (+/- 5%) over past 3 months

You may not qualify if:

  • Self-reported cardiovascular disease
  • Additional self-reported medical conditions
  • Medications known to affect metabolism
  • Excess caffeine use
  • Self-reported contradictions according to ACSM
  • Unwillingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Research Center University of South Carolina

Columbia, South Carolina, 29201, United States

Location

Related Links

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xuewen Wang, PhD, MEd, BM

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 24, 2012

First Posted

November 6, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 19, 2019

Record last verified: 2016-05

Locations

US(1)