Pre-Clinically DisabledPhase 1TSENCT01183507
Task Specific Exercise for the Prevention of Disability
A Phase 1 study testing NIA intervention and TSE in people with Pre-Clinically Disabled, run by University of Florida at 2 sites in United States.
Trial summary
The purpose of this research study is to evaluate the effect of two different exercise programs on physical function in men and women 60 years of age and older. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pre-Clinically Disabled
- What is being tested?
- NIA intervention and TSE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Aug 2016
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 60+ years
- Self-report no difficulty walking ½ mile, climbing steps, stooping-crouching-kneeling, getting up off the floor, or lifting/carrying something as heavy as 10 lbs
- Modified the method of frequency of walking ½ mile, climbing steps, stooping-crouching-kneeling, getting up off the floor or lifting/carrying something as heavy as 10 lbs
- Observed use of 7 or more modifications plus a score of 2 or greater on at least two tasks on the MOD scale
- Sedentary lifestyle ( < 125 minutes walking or performing aerobic exercise)
- Successful completion of the behavioral run-in without the assistance of a spouse or other family or friend
- Willing and able to participate in all aspects of the pilot study, i.e., randomization, pre- and post-testing, home evaluation
- Willing to give and informed consent
Who cannot join
- Self-reporting having "any difficulty" walking ½ mile, climbing steps, stooping-crouching-kneeling, getting up off the floor, or lifting/carrying something as heavy as 10 lbs
- Failure to give consent
- Active Treatment for cancer
- Stroke (<6 mo)
- Neurological disorder
- Peripheral vascular disease
Show all 21Show fewer
- Congestive heart failure (NYHA class II, III or IV), coronary artery disease (myocardial infarction <6 mo) or valvular heart disease
- Major psychiatric disease
- Severe anemia
- Liver or renal disease
- Uncontrolled diabetes or hypertension
- Macular degeneration
- Blindness or deafness
- Orthopedic impairment
- Rheumatoid arthritis or severe osteoarthritis
- Fracture in upper or lower extremity within last 6 months
- Upper or lower extremity amputation
- Participation in another intervention trial
- Inability to perform exercise due to severe physical disability
- MMSE < 24
- Plans to move within the next year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Aging and Rehabilitation Research Center
Gainesville, Florida, 32611
UF Institute on Aging Health Promotion Center
Gainesville, Florida, 32611
About this study
Official title: Task Specific Exercise for the Pre-Clinically Disabled
The purpose of this research study is to evaluate the effect of two different exercise programs on physical function in men and women 60 years of age and older.
Read the detailed description
Pre-clinical disability is an early warning system in the disablement process as it is characterized by selecting to perform everyday tasks less often and compensating for those tasks still being performed. This phase serves as an ideal target for preventative strategies because treatments can be designed for individuals on the verge of disability thus interrupting the occurrence of outright disability. One such strategy that optimizes the transfer of adaptations to real-life situations is task-specific exercise (TSE). This type of intervention holds promise to determine how pre-clinically disabled older adults might interrupt the disablement process and instead begin an enablement process and thus lead us to better interventions to treat and prevent disability from occurring. However, because of the complexity of the disablement process, it has been extremely challenging to objectively identify outcomes that represent changes in selection, optimization, and compensation of tasks (the SOC domains). The objective of the current application is first, to ask what are the short and long-term responses of TSE in the pre-clinically disabled older adults (aged 60+ years). Thirdly, we will shed exciting new light on whether TSE alters neuromechanical and psychological factors. We want to know this, in part, from a mechanistic perspective to gain insight into the processes by which TSE improves disablement outcomes. Also, this will help us to better understand how to enhance the TSE intervention to treat pre-clinically disabled patients. Thus, we offer two hypotheses: Hypothesis #1: TSE increases selection and optimization of everyday tasks, while reducing compensation to achieve task performance. Hypothesis #2. TSE mediates changes in SOC domains through both neuromechanical (decrease variability of movement and increase muscle work capacity) and psychological (increased confidence to perform tasks and increased executive function) properties. These data are expected to guide us in designing a randomized controlled trial that will test whether TSE in the pre-clinically disabled can reduce future incidence of outright disability.
- Conditions
- Pre-Clinically Disabled
- Being tested
- NIA intervention, TSE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIA interventionBehavioural
The NIA physical activity intervention is of moderate intensity and will consist of aerobic, strength, flexibility, and balance training, with a target duration of 120 minutes per week.
TSEBehavioural
The TSE intervention is also of moderate intensity and target duration of 120 minutes per week and will consist of exercises that closely mimic functional tasks, such as vacuuming, stair ascent and descent, and lifting a weighted laundry basket.
| Study group | Role | What they receive |
|---|---|---|
| NIA intervention | Active comparator | Not described Receives: Behavioral: NIA intervention |
| TSE intervention | Experimental | Not described Receives: Behavioral: TSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOD Score
Number of modifications used by participants in the performance daily activities
Measured: Screening, 6, 12, 24 weeks
Secondary outcomes (3)
400 m walk
The 400-m walk was chosen because, clinically, it has been proposed as a threshold of high level of performance and is strongly associated with measures of functional limitations, disability and mortality, and predicts future loss of ability to complete the walk. The ability to walk 400 meters has demonstrated excellent test-retest reliability (Kappa = 1.0), based on independent assessments completed 1-7 days apart among 60 physically impaired older persons.
Measured: Baseline, 12, 24 wks
Short Physical Performance Battery
The SPPB, based on a timed short distance walk, repeated chair stands and balance test (as described by Guralnik et al.), will be used to demonstrate the physical function of older adults. Each of the 3 performance measures will be assigned a score ranging from 0 to 4.
Measured: Baseline, 12, 24 wks
Late Life Function and Disability Instrument
The Late Life Function and Disability Instrument, developed by Dr. Jette et al., will be used to document disability status using a scale from 0 to 100, with higher scores indicating higher levels of function. The instrument includes 16 tasks representing a broad range of disability indicators that assesses both frequency of doing a task and perceived limitation, and was developed using more contemporary psychometric techniques (Rasch models). The scale has recently shown strong concurrent and predictive validity with physical performance.
Measured: Baseline, 12, 24 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2012
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Clinically DisabledStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Todd Manini, PhD, Principal investigator, University of Florida Department of Aging and Geriatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183507
- Sponsor's protocol ID
- 410-2009
- Other IDs
- 1R21AG031974-01A2
- Acronym
- TSE
- Status last verified
- Sep 2016
- First submitted
- 16 Aug 2010
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task Specific Exercise for the Pre-Clinically Disabled
- ClinicalTrials.gov ID
- NCT01183507
- Acronym / sponsor ID
- TSE / 410-2009
- Conditions
- Pre-Clinically Disabled
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Apr 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Aug 2010 (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 purpose of this research study is to evaluate the effect of two different exercise programs on physical function in men and women 60 years of age and older.
Detailed description
Pre-clinical disability is an early warning system in the disablement process as it is characterized by selecting to perform everyday tasks less often and compensating for those tasks still being performed. This phase serves as an ideal target for preventative strategies because treatments can be designed for individuals on the verge of disability thus interrupting the occurrence of outright disability. One such strategy that optimizes the transfer of adaptations to real-life situations is task-specific exercise (TSE). This type of intervention holds promise to determine how pre-clinically disabled older adults might interrupt the disablement process and instead begin an enablement process and thus lead us to better interventions to treat and prevent disability from occurring. However, because of the complexity of the disablement process, it has been extremely challenging to objectively identify outcomes that represent changes in selection, optimization, and compensation of tasks (the SOC domains). The objective of the current application is first, to ask what are the short and long-term responses of TSE in the pre-clinically disabled older adults (aged 60+ years). Thirdly, we will shed exciting new light on whether TSE alters neuromechanical and psychological factors. We want to know this, in part, from a mechanistic perspective to gain insight into the processes by which TSE improves disablement outcomes. Also, this will help us to better understand how to enhance the TSE intervention to treat pre-clinically disabled patients. Thus, we offer two hypotheses: Hypothesis #1: TSE increases selection and optimization of everyday tasks, while reducing compensation to achieve task performance. Hypothesis #2. TSE mediates changes in SOC domains through both neuromechanical (decrease variability of movement and increase muscle work capacity) and psychological (increased confidence to perform tasks and increased executive function) properties. These data are expected to guide us in designing a randomized controlled trial that will test whether TSE in the pre-clinically disabled can reduce future incidence of outright disability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIA intervention | Active comparator | Behavioral: NIA intervention |
| TSE intervention | Experimental | Behavioral: TSE |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 60+ years
- Self-report no difficulty walking ½ mile, climbing steps, stooping-crouching-kneeling, getting up off the floor, or lifting/carrying something as heavy as 10 lbs
- Modified the method of frequency of walking ½ mile, climbing steps, stooping-crouching-kneeling, getting up off the floor or lifting/carrying something as heavy as 10 lbs
- Observed use of 7 or more modifications plus a score of 2 or greater on at least two tasks on the MOD scale
- Sedentary lifestyle ( < 125 minutes walking or performing aerobic exercise)
Key exclusion criteria (21 listed)
- Self-reporting having "any difficulty" walking ½ mile, climbing steps, stooping-crouching-kneeling, getting up off the floor, or lifting/carrying something as heavy as 10 lbs
- Failure to give consent
- Active Treatment for cancer
- Stroke (<6 mo)
- Neurological disorder
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 |
|---|---|---|
| NIA interventionThe NIA physical activity intervention is of moderate intensity and will consist of aerobic, strength, flexibility, and balance training, with a target duration of 120 minutes per week. | Behavioural | NIA intervention |
| TSEThe TSE intervention is also of moderate intensity and target duration of 120 minutes per week and will consist of exercises that closely mimic functional tasks, such as vacuuming, stair ascent and descent, and lifting a weighted laundry basket. | Behavioural | TSE intervention |
Primary outcome
MOD Score
Time frame: Screening, 6, 12, 24 weeks
Number of modifications used by participants in the performance daily activities
3 secondary outcomes
400 m walk
Time frame: Baseline, 12, 24 wks
Short Physical Performance Battery
Time frame: Baseline, 12, 24 wks
Late Life Function and Disability Instrument
Time frame: Baseline, 12, 24 wks
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 Sep 2016.
- UF Department of AgingLink provided by the sponsor.
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.
Todd Manini, PhD principal investigator
University of Florida Department of Aging and Geriatric Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NIA intervention and TSE in people with Pre-Clinically Disabled, run by University of Florida 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 8 inclusion and 21 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 Sep 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MOD Score (time frame: Screening, 6, 12, 24 weeks). 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 30 Sep 2016.