- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464254
Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE) (INSPIRE)
June 19, 2019 updated by: Weill Medical College of Cornell University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Charlson Index greater or equal to 3
Exclusion Criteria:
- Cognitive impairment
- Inability to walk
- < 12 month anticipated survival
- enrollment in other behavioral programs
- lack of medical approval to participate
- substance/alcohol dependence or participation in a substance abuse treatment program within 12 months
- major psychiatric illness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical activity plus positive affect
Subjects will be randomized to a physical activity goal and the positive affect component
|
Subjects will be randomized to a physical activity goal and will receive the positive affect component.
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
|
Subjects will be randomized to a physical activity goal and will receive the educational component.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kilocalories/week assessed by Objective measure of activity with accelerometry
Time Frame: baseline to 12 months
|
FitBit
|
baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Kilocalories/week assessed by Subjective measure of activity by self-report
Time Frame: baseline to 12 months
|
baseline to 12 months
|
Function/disability assessed by objective and subjective reports of functional ability
Time Frame: baseline to 12 months
|
baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Janey Peterson, EdD MS RN, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Anticipated)
December 30, 2019
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
June 2, 2015
First Submitted That Met QC Criteria
June 3, 2015
First Posted (Estimate)
June 8, 2015
Study Record Updates
Last Update Posted (Actual)
June 21, 2019
Last Update Submitted That Met QC Criteria
June 19, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1303013686
- 1K23AG042869-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in the main article reporting the results, after deidentification
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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