ElderlyFITNCT01899586
Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly
A study testing Regional Specific Training Stimulus (RSTS) and Aerobic Exercise Regimen (AE) in people with Elderly and Sedentary, run by Duke University at 2 sites in United States.
Trial summary
The aim of this study is to devise a sufficiently high intensity training program that provided an optimal stimulus to remove the peripheral factors known to reduce functional capacity, and can be cardiovascular and orthopedically well tolerated by the elderly. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- What is being tested?
- Regional Specific Training Stimulus (RSTS) and Aerobic Exercise Regimen (AE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Nov 2011
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- >70 yrs of age
- Sedentary (exercising <1 day/wk)
- Non-smokers
- Able to ambulate without use of an assistive device
- Able to walk between 200-450m on a 6-minute walk test
Who cannot join
- Oxygen dependent
- Recent medications changes (within 3 months)
- Current Smokers
- Fixed-rate pacemakers
- Uncontrolled hypertension or Type II diabetes
- Positive ECG changes or angina during CPX testing
- Unable to complete a maximal CPX to volitional fatigue
- AHA Class D, or NYHA Class III or IV heart failure
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Center
Baton Rouge, Louisiana, 70808
Duke Center for Living; Wallace Clinic
Durham, North Carolina, 27710
About this study
The aim of this study is to devise a sufficiently high intensity training program that provided an optimal stimulus to remove the peripheral factors known to reduce functional capacity, and can be cardiovascular and orthopedically well tolerated by the elderly. Findings from study laboratories have suggested that a regional specific training stimulus (RSTS) results in rapid improvements in both vascular and muscular function. RSTS is a novel combination of resistance training and aerobic training applied simultaneously, and in a serial manner, to specific regions of the body. It involves high-intensity and frequency muscle contractions, generating a targeted exercise stimulus, without producing excessive cardiovascular or orthopedic stress. The hypothesis is that initiating training with RSTS at multiple, strategically selected peripheral sites, in a serial manner will elicit local vascular and muscular changes, thereby preparing individuals at elevated risk of losing independence, to respond and progress more favorably to whole-body exercise.
- Being tested
- Regional Specific Training Stimulus (RSTS), Aerobic Exercise Regimen (AE)
- Keywords
- Aging, Functional Capacity, Exercise Independence, Peripheral Adaptations, Vascular
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional Specific Training Stimulus (RSTS)Other
The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises.
Aerobic Exercise Regimen (AE)Other
Whole-body aerobic exercise at >50% of heart rate reserve (HRR) for 45 minutes, three days per week.
| Study group | Role | What they receive |
|---|---|---|
| Regional Specific Training (RSTS) | Experimental | The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises. Receives: Other: Regional Specific Training Stimulus (RSTS) |
| Aerobic Exercise (AE) | Experimental | Whole-body aerobic exercise at >50% of heart rate reserve (HRR) for 45 minutes, three days per week. Receives: Other: Aerobic Exercise Regimen (AE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Exercise Capacity
Exercise capacity was assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption and peak walking time.
Measured: Baseline, 4 weeks, and 12 weeks
Change in Maximal Strength
Skeletal muscle strength was assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.
Measured: Baseline, 4 weeks, and 12 weeks
Secondary outcomes (3)
Change in Functional Ability
The Senior Fitness Test is a previously validated battery of 6 physical tasks of daily living used to assess strength, flexibility and endurance in order to detect and predict future limitations in functional capacity. The test is designed to evaluate physical fitness domains including upper-body strength (Arm Curl), lower-body strength (Chair Sit-Stand), upper and lower body flexibility (Back Scratch and Chair Sit and Reach), balance and coordination (8 foot Up and Go), and endurance (Six Minute Walk).
Measured: Baseline, 4 weeks and 12 Weeks
Change In Vascular Function
Ankle-brachial Index (ABI), Brachial artery flow-mediated dilation (BAFMD), and arterial stiffness (pulse wave velocity and pulse wave reflection).
Measured: Baseline, 4 weeks, and 12 weeks
Change in Skeletal Muscle Physiology
Capillary density (mm2) and capillary to fiber ratio will be evaluated. Fiber type will be also determined to identify for types I, IIa and IIb muscle fibers.
Measured: Baseline, 4 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startSep 2009
- Primary completionNov 2011
- Study completionNov 2011
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 ElderlyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jason D Allen, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899586
- Sponsor's protocol ID
- Pro00019806
- Other IDs
- 1RC1AG035822-01
- Acronym
- FIT
- Status last verified
- Feb 2014
- First submitted
- 11 Jul 2013
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Woessner MN, Welsch MA, VanBruggen MD, Johannsen NM, Credeur DP, Pieper CF, Sloane R, Earnest CP, Ortiz De Zevallos Munoz J, Church TS, Ravussin E, Kraus WE, Allen JD. Impact of a Novel Training Approach on Hemodynamic and Vascular Profiles in Older Adults. J Aging Phys Act. 2022 Apr 1;30(2):196-203. doi: 10.1123/japa.2020-0509. Epub 2021 Aug 4.
PubMed 34348230
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly
- ClinicalTrials.gov ID
- NCT01899586
- Acronym / sponsor ID
- FIT / Pro00019806
- Keywords
- Aging, Functional Capacity, Exercise Independence, Peripheral Adaptations, Vascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Jul 2013 (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 aim of this study is to devise a sufficiently high intensity training program that provided an optimal stimulus to remove the peripheral factors known to reduce functional capacity, and can be cardiovascular and orthopedically well tolerated by the elderly. Findings from study laboratories have suggested that a regional specific training stimulus (RSTS) results in rapid improvements in both vascular and muscular function. RSTS is a novel combination of resistance training and aerobic training applied simultaneously, and in a serial manner, to specific regions of the body. It involves high-intensity and frequency muscle contractions, generating a targeted exercise stimulus, without producing excessive cardiovascular or orthopedic stress. The hypothesis is that initiating training with RSTS at multiple, strategically selected peripheral sites, in a serial manner will elicit local vascular and muscular changes, thereby preparing individuals at elevated risk of losing independence, to respond and progress more favorably to whole-body exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional Specific Training (RSTS) | Experimental | Other: Regional Specific Training Stimulus (RSTS)The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises. |
| Aerobic Exercise (AE) | Experimental | Other: Aerobic Exercise Regimen (AE)Whole-body aerobic exercise at >50% of heart rate reserve (HRR) for 45 minutes, three days per week. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- >70 yrs of age
- Sedentary (exercising <1 day/wk)
- Non-smokers
- Able to ambulate without use of an assistive device
- Able to walk between 200-450m on a 6-minute walk test
Key exclusion criteria (8 listed)
- Oxygen dependent
- Recent medications changes (within 3 months)
- Current Smokers
- Fixed-rate pacemakers
- Uncontrolled hypertension or Type II diabetes
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 |
|---|---|---|
| Regional Specific Training Stimulus (RSTS)The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises. | Other | Regional Specific Training (RSTS) |
| Aerobic Exercise Regimen (AE)Whole-body aerobic exercise at >50% of heart rate reserve (HRR) for 45 minutes, three days per week. | Other | Aerobic Exercise (AE) |
Primary outcome
Change In Exercise Capacity
Time frame: Baseline, 4 weeks, and 12 weeks
Exercise capacity was assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption and peak walking time.
Change in Maximal Strength
Time frame: Baseline, 4 weeks, and 12 weeks
Skeletal muscle strength was assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.
3 secondary outcomes
Change in Functional Ability
Time frame: Baseline, 4 weeks and 12 Weeks
Change In Vascular Function
Time frame: Baseline, 4 weeks, and 12 weeks
Change in Skeletal Muscle Physiology
Time frame: Baseline, 4 weeks, and 12 weeks
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 4 Mar 2014.
- Derived from this study: PubMed 34348230Woessner MN, Welsch MA, VanBruggen MD, Johannsen NM, Credeur DP, Pieper CF, Sloane R, Earnest CP, Ortiz De Zevallos Munoz J, Church TS, Ravussin E, Kraus WE, Allen JD. Impact of a Novel Training Approach on Hemodynamic and Vascular Profiles in Older Adults. J Aging Phys Act. 2022 Apr 1;30(2):196-203. doi: 10.1123/japa.2020-0509. Epub 2021 Aug 4.
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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.
Jason D Allen, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional Specific Training Stimulus (RSTS) and Aerobic Exercise Regimen (AE) in people with Elderly and Sedentary, run by Duke University at 2 sites 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 5 inclusion and 8 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 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 In Exercise Capacity (time frame: Baseline, 4 weeks, and 12 weeks). The study lists 2 primary outcomes in all. 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 NCT01899586, 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 4 Mar 2014.