ConditionWWNCT01722136
"We Walk": Impact of Exercise Dose on Health Outcomes Among Women Ages 60-75
A study testing Low Dosage and High Dosage in people with Condition, run by University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Condition
- What is being tested?
- Low Dosage and High Dosage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Public Health Research Center University of South Carolina
Columbia, South Carolina, 29201
About this study
Official title: We Walk - Energy Expenditure and Health Outcomes in Older, Sedentary Women.
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.
Read the detailed description
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. Changes in all components of energy expenditure, as well as concentrations of plasma leptin and serum free T3, in response to the two different exercise programs (14 and 8 kcal/kg body weight weekly, 60-65% VO2max, 4 days/wk) will be compared in older, non-obese women (60-75 yrs, BMI=18-30 kg/m2).
Specific Aim 1: To determine whether differential changes in total daily energy expenditure and its components occur in older women in response to two exercise programs of different doses. State-of-the-art methods will be used (total daily energy expenditure by doubly labeled water; non-exercise activity thermogenesis using Physical Activity Monitoring System; resting metabolic rate and thermic effect of food via indirect calorimetry).
Primary Hypothesis: Due to a greater decline in NEAT, women will exhibit a smaller increase in total daily energy expenditure in response to the higher-dose, compared to the lower-dose, exercise program, despite greater increases in resting metabolic rate and thermic effect of food.
Specific Aim 2: To explore whether differential changes occur in plasma leptin and serum free triiodo-L-thyronine (free T3) concentrations in older women in response to 16-week aerobic exercise programs of two different doses.
We hypothesize that in response to the higher-dose exercise program, women will exhibit larger decreases in plasma leptin and serum free T3 concentrations, compared to the lower-dose exercise program.
We will also determine whether women exhibit greater improvements in plasma lipids, insulin sensitivity (using homeostasis model assessment, HOMA, score), blood pressure, and aerobic fitness in response to the higher-dose, compared to the lower-dose, exercise program.
- Conditions
- Condition
- Being tested
- Low Dosage, High Dosage
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low DosageBehavioural
Exercise dose of 8kcal/kg/week
High DosageBehavioural
Exercise dose of 14kcal/kg/week
| Study group | Role | What they receive |
|---|---|---|
| Low Dosage | Experimental | Exercise dose of 8kcal/kg/week Receives: Behavioral: Low Dosage |
| High Dosage | Experimental | Exercise dose 14kcal/kg/week Receives: Behavioral: High Dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline total daily energy expenditure and its components (resting metabolic rate, thermic effect of food, non-exercise activity thermogenesis)in 4 months
Measured: 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
Measured: Baseline (pre-intervention); 4 month (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConditionStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuewen Wang, University of South Carolina
- Investigators
- Xuewen Wang, PhD, MEd, BM, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722136
- Sponsor's protocol ID
- Pro00016306
- Acronym
- WW
- Status last verified
- May 2016
- First submitted
- 24 Oct 2012
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- We Walk - Energy Expenditure and Health Outcomes in Older, Sedentary Women.
- ClinicalTrials.gov ID
- NCT01722136
- Acronym / sponsor ID
- WW / Pro00016306
- Conditions
- Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Changes in all components of energy expenditure, as well as concentrations of plasma leptin and serum free T3, in response to the two different exercise programs (14 and 8 kcal/kg body weight weekly, 60-65% VO2max, 4 days/wk) will be compared in older, non-obese women (60-75 yrs, BMI=18-30 kg/m2).
Specific Aim 1: To determine whether differential changes in total daily energy expenditure and its components occur in older women in response to two exercise programs of different doses. State-of-the-art methods will be used (total daily energy expenditure by doubly labeled water; non-exercise activity thermogenesis using Physical Activity Monitoring System; resting metabolic rate and thermic effect of food via indirect calorimetry).
Primary Hypothesis: Due to a greater decline in NEAT, women will exhibit a smaller increase in total daily energy expenditure in response to the higher-dose, compared to the lower-dose, exercise program, despite greater increases in resting metabolic rate and thermic effect of food.
Specific Aim 2: To explore whether differential changes occur in plasma leptin and serum free triiodo-L-thyronine (free T3) concentrations in older women in response to 16-week aerobic exercise programs of two different doses.
We hypothesize that in response to the higher-dose exercise program, women will exhibit larger decreases in plasma leptin and serum free T3 concentrations, compared to the lower-dose exercise program.
We will also determine whether women exhibit greater improvements in plasma lipids, insulin sensitivity (using homeostasis model assessment, HOMA, score), blood pressure, and aerobic fitness in response to the higher-dose, compared to the lower-dose, exercise program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dosage | Experimental | Behavioral: Low DosageExercise dose of 8kcal/kg/week |
| High Dosage | Experimental | Behavioral: High DosageExercise dose 14kcal/kg/week |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Self-reported cardiovascular disease
- Additional self-reported medical conditions
- Medications known to affect metabolism
- Excess caffeine use
- Self-reported contradictions according to ACSM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low DosageExercise dose of 8kcal/kg/week | Behavioural | Low Dosage |
| High DosageExercise dose of 14kcal/kg/week | Behavioural | High Dosage |
Primary outcome
Change from baseline total daily energy expenditure and its components (resting metabolic rate, thermic effect of food, non-exercise activity thermogenesis)in 4 months
Time frame: Baseline (pre-intervention); 4 months (post-intervention)
1 secondary outcome
Change from baseline plasma leptin and serum free triiodo-L-thyronine (free T3) concentrations in 4 months
Time frame: Baseline (pre-intervention); 4 month (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Brief description of study for potential participantsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuewen Wang, PhD, MEd, BM principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dosage and High Dosage in people with Condition, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline total daily energy expenditure and its components (resting metabolic rate, thermic effect of food, non-exercise activity thermogenesis)in 4 months (time frame: Baseline (pre-intervention); 4 months (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.