AgingNCT00283673
Effect of Exercise Intervention on Various Physiologic Factors That Change With Increasing Age
A study testing Exercise in people with Aging, run by Mayo Clinic at 1 site in United States.
Trial summary
This study randomized healthy sedentary people age 20-80 years to 16 weeks of supervised exercise versus no exercise. Several end points were evaluated after 16 weeks including insulin sensitivity and muscle physiology. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1995to Jan 1998
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Healthy subjects performing < 30 min exercise twice per week. Age 20-90 years. Willing to be randomized to exercise versus no exercise. Willing to be studied in General Clinical Research Center with studies including Muscle Biopsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Aerobic Exercise Training on Age Related Changes in Insulin Sensitivity and Muscle Oxidative Capacity
This study randomized healthy sedentary people age 20-80 years to 16 weeks of supervised exercise versus no exercise. Several end points were evaluated after 16 weeks including insulin sensitivity and muscle physiology.
Read the detailed description
Healthy subjects performing < 30 min exercise twice per week were studied prior to randomization and after of sixteen weeks exercise. They were randomized to sixteen weeks of supervised exercise performed on a stationary bike vs. placebo exercise (a series of flexibility exercises performed at home). Intensity, duration and frequency of exercise were gradually increased to four sessions per week lasting forty minutes each and achieving 80% target heart rate. Participants were weighed perioidically and counseled appropriately when weight changed by > 2 %. Insulin sensitivity and muscle mitochondrial protein synthesis were studied.
- Conditions
- Aging
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Secondary outcomes (3)
Muscle Mitochondrial Protein Synthesis
mRNA of mitochondrial genes
mRNA of genes involved in mitochondrial biogenesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startSep 1995
- Primary completionJan 1998
- Study completionJan 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 102 participants
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- K. Sreekumaran Nair, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283673
- Sponsor's protocol ID
- 350-95
- Other IDs
- R01AG009531
- Status last verified
- Jun 2011
- First submitted
- 27 Jan 2006
- Last updated
- 6 Jun 2011
- Results posted
- No
Publications
Short KR, Vittone JL, Bigelow ML, Proctor DN, Rizza RA, Coenen-Schimke JM, Nair KS. Impact of aerobic exercise training on age-related changes in insulin sensitivity and muscle oxidative capacity. Diabetes. 2003 Aug;52(8):1888-96. doi: 10.2337/diabetes.52.8.1888.
PubMed 12882902
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobic Exercise Training on Age Related Changes in Insulin Sensitivity and Muscle Oxidative Capacity
- ClinicalTrials.gov ID
- NCT00283673
- Acronym / sponsor ID
- 350-95
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 1995
- Primary completion
- Jan 1998 (actual)
- Study completion
- Jan 1998 (actual)
- First posted
- 30 Jan 2006 (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.
This study randomized healthy sedentary people age 20-80 years to 16 weeks of supervised exercise versus no exercise. Several end points were evaluated after 16 weeks including insulin sensitivity and muscle physiology.
Detailed description
Healthy subjects performing < 30 min exercise twice per week were studied prior to randomization and after of sixteen weeks exercise. They were randomized to sixteen weeks of supervised exercise performed on a stationary bike vs. placebo exercise (a series of flexibility exercises performed at home). Intensity, duration and frequency of exercise were gradually increased to four sessions per week lasting forty minutes each and achieving 80% target heart rate. Participants were weighed perioidically and counseled appropriately when weight changed by > 2 %. Insulin sensitivity and muscle mitochondrial protein synthesis were studied.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Exercise | Behavioural | – |
Primary outcome
Insulin sensitivity
3 secondary outcomes
Muscle Mitochondrial Protein Synthesis
mRNA of mitochondrial genes
mRNA of genes involved in mitochondrial biogenesis
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 6 Jun 2011.
- Results publication: PubMed 12882902Short KR, Vittone JL, Bigelow ML, Proctor DN, Rizza RA, Coenen-Schimke JM, Nair KS. Impact of aerobic exercise training on age-related changes in insulin sensitivity and muscle oxidative capacity. Diabetes. 2003 Aug;52(8):1888-96. doi: 10.2337/diabetes.52.8.1888.
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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.
K. Sreekumaran Nair, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Aging, run by Mayo Clinic 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?
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 6 Jun 2011. 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?
Insulin sensitivity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00283673, which also lists 1 linked publication.
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 6 Jun 2011.