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

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ClinicalTrials.gov Identifier: NCT02464254
Recruitment Status : Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Chronic Illnesses Behavioral: Physical activity plus positive affect Behavioral: Physical activity plus education Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE)
Study Start Date : April 2016
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical activity plus positive affect
Subjects will be randomized to a physical activity goal and the positive affect component
Behavioral: Physical activity plus positive affect
Subjects will be randomized to a physical activity goal and will receive the positive affect component.

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

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




Primary Outcome Measures :
  1. Kilocalories/week assessed by Objective measure of activity with accelerometry [ Time Frame: baseline to 12 months ]
    FitBit


Secondary Outcome Measures :
  1. Kilocalories/week assessed by Subjective measure of activity by self-report [ Time Frame: baseline to 12 months ]
  2. Function/disability assessed by objective and subjective reports of functional ability [ Time Frame: baseline to 12 months ]


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Ages Eligible for Study:   60 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464254


Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Janey Peterson, EdD MS RN Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02464254     History of Changes
Other Study ID Numbers: 1303013686
1K23AG042869-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Weill Medical College of Cornell University:
Physical activity, positive affect, older adults, aging

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes