This trial is active, not recruiting.

Condition pre-clinically disabled
Treatments nia intervention, tse
Phase phase 1
Sponsor University of Florida
Collaborator National Institutes of Health (NIH)
Start date April 2010
End date April 2012
Trial size 71 participants
Trial identifier NCT01183507, 1R21AG031974-01A2, 410-2009


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
(Active Comparator)
nia intervention
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.
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.

Primary Outcomes

MOD Score
time frame: Screening, 6, 12, 24 weeks

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

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Additional Information

Official title Task Specific Exercise for the Pre-Clinically Disabled
Principal investigator Todd Manini, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Florida.