Clinical trial NCT02464254: Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE)
Official title: Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Illnesses
Keywords: Physical activity, positive affect, older adults, aging
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will conduct a 1-year prospective and randomized study to evaluate the initial efficacy of positive affect vs. an educational control to motivate physical activity in older adults with high burdens of chronic disease.

Detailed description: Older adults with multiple chronic diseases are at high risk for both disability and adverse clinical events, outcomes that can be improved with physical activity, but there have been no trials to establish physical activity recommendations or clinical guidelines for this vulnerable population. A recent randomized controlled trial conducted by Dr. Peterson established the efficacy of inducing positive affect-a feeling of happiness and well-being-in motivating physical activity in older adults with cardiovascular disease. This new randomized controlled trial will pilot test the a new PAIRE (Positive Affect Induction for Regular Exercise) intervention that is specific to older adults with multiple high-risk chronic illnesses versus an educational control group. This work is innovative because it will translate the benefits of a proven intervention focused on positive affect to increase physical activity in older adults with multiple high-risk chronic illnesses, one that is tailored to the clinical and psychosocial challenges of this particularly vulnerable population. This work is significant because an effective intervention promoting physical activity will improve outcomes for older adults with multiple high-risk chronic diseases, and currently one does not exist.

Eligibility criteria: Inclusion Criteria:

* Charlson Index greater or equal to 3

Exclusion Criteria:

1. Cognitive impairment
2. Inability to walk
3. \< 12 month anticipated survival
4. enrollment in other behavioral programs
5. lack of medical approval to participate
6. substance/alcohol dependence or participation in a substance abuse treatment program within 12 months
7. major psychiatric illness.

Primary outcomes:
measure: Kilocalories/week assessed by Objective measure of activity with accelerometry
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Kilocalories/week assessed by Subjective measure of activity by self-report
timeFrame: baseline to 12 months
measure: Function/disability assessed by objective and subjective reports of functional ability
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Janey Peterson, EdD MS RN
role: PRINCIPAL_INVESTIGATOR
References: