Physical FunctionNCT01385475
Resistance Training to Improve Physical Function in the Elderly
A study testing RT in people with Physical Function, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
The primary purpose of this study is to examine the effectiveness of the current resistance training guidelines for older adults proposed by ACSM/AHA to improve physical function in individuals with reduced physical abilities. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Function
- What is being tested?
- RT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older Adults aged >65yrs; reduced physical function
Who cannot join
- Those with a history of resistance training
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Activity & Health Research Laboratory
Milwaukee, Wisconsin, 53211
About this study
Official title: Efficacy of Resistance Training Guidelines to Improve Function in Older Adults
The primary purpose of this study is to examine the effectiveness of the current resistance training guidelines for older adults proposed by ACSM/AHA to improve physical function in individuals with reduced physical abilities. A randomized controlled intervention trial will be used to compare change in physical function pre- and post-intervention between a treatment group receiving the minimum recommendations of the guidelines and a control group asked not to change their physical activity participation. To better understand the clinical significance of such an occurrence, a secondary purpose was to determine if older adults with reduced physical abilities who adhere to the recommended intervention dosage will experience a change such that they can be reclassified to a more favorable level of functioning. It is hypothesized that the minimum recommended dosage of the guidelines would be sufficient to both improve physical function and improve functional classification in older adults with reduced physical abilities.
- Conditions
- Physical Function
- Being tested
- RT
- Keywords
- Resistance Training, Physical Function, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTBehavioural
8 week RT Intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Not described Receives: Behavioral: RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality
Change in Short Performance Physical Battery (SPPB) score is used as a measure of functionality. The SPPB consists of three tasks designed to assess gait speed, and ability to rise from a chair and maintain standing balance. This is a common test to assess function, with scores ranging from 0-12. The higher score equates to a better level of function.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionJun 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 Physical FunctionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Investigators
- Scott J Strath, PhD, Study director, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385475
- Sponsor's protocol ID
- RTFunction
- Other IDs
- K01AG025962
- Status last verified
- Jun 2011
- First submitted
- 22 Jun 2011
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gennuso KP, Zalewski K, Cashin SE, Strath SJ. Resistance training congruent with minimal guidelines improves function in older adults: a pilot study. J Phys Act Health. 2013 Aug;10(6):769-76. doi: 10.1123/jpah.10.6.769. Epub 2012 Oct 10.
PubMed 23074076
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Resistance Training Guidelines to Improve Function in Older Adults
- ClinicalTrials.gov ID
- NCT01385475
- Acronym / sponsor ID
- RTFunction
- Conditions
- Physical Function
- Keywords
- Resistance Training, Physical Function, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Jun 2011 (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 primary purpose of this study is to examine the effectiveness of the current resistance training guidelines for older adults proposed by ACSM/AHA to improve physical function in individuals with reduced physical abilities. A randomized controlled intervention trial will be used to compare change in physical function pre- and post-intervention between a treatment group receiving the minimum recommendations of the guidelines and a control group asked not to change their physical activity participation. To better understand the clinical significance of such an occurrence, a secondary purpose was to determine if older adults with reduced physical abilities who adhere to the recommended intervention dosage will experience a change such that they can be reclassified to a more favorable level of functioning. It is hypothesized that the minimum recommended dosage of the guidelines would be sufficient to both improve physical function and improve functional classification in older adults with reduced physical abilities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: RT |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Older Adults aged >65yrs; reduced physical function
Key exclusion criteria (1 listed)
- Those with a history of resistance training
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 |
|---|---|---|
| RT8 week RT Intervention | Behavioural | Control |
Primary outcome
Functionality
Time frame: 8 weeks
Change in Short Performance Physical Battery (SPPB) score is used as a measure of functionality. The SPPB consists of three tasks designed to assess gait speed, and ability to rise from a chair and maintain standing balance. This is a common test to assess function, with scores ranging from 0-12. The higher score equates to a better level of function.
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 30 Jun 2011.
- Derived from this study: PubMed 23074076Gennuso KP, Zalewski K, Cashin SE, Strath SJ. Resistance training congruent with minimal guidelines improves function in older adults: a pilot study. J Phys Act Health. 2013 Aug;10(6):769-76. doi: 10.1123/jpah.10.6.769. Epub 2012 Oct 10.
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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.
Scott J Strath, PhD study director
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT in people with Physical Function, run by University of Wisconsin, Milwaukee 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 1 inclusion and 1 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 30 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?
Functionality (time frame: 8 weeks). 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 NCT01385475, 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 30 Jun 2011.