Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE)

Chronic Illnesses Clinical Trial

— INSPIRE  

Official title:

Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02464254
• Other study ID #: 1303013686
• Secondary ID: 1K23AG042869-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illnesses

Intervention

Behavioral:
• Physical activity plus positive affect
Subjects will be randomized to a physical activity goal and will receive the positive affect component.
• Physical activity plus education
Subjects will be randomized to a physical activity goal and will receive the educational component.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kilocalories/week assessed by Objective measure of activity with accelerometry	FitBit	baseline to 12 months
Secondary	Kilocalories/week assessed by Subjective measure of activity by self-report		baseline to 12 months
Secondary	Function/disability assessed by objective and subjective reports of functional ability		baseline to 12 months