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

Primary Purpose

Chronic Illnesses

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity plus positive affect
Physical activity plus education
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Illnesses focused on measuring Physical activity, positive affect, older adults, aging

Eligibility Criteria

60 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical activity plus positive affect

Physical activity plus education

Arm Description

Subjects will be randomized to a physical activity goal and the positive affect component

Subjects will be randomized to a physical activity goal and education

Outcomes

Primary Outcome Measures

Kilocalories/week assessed by Objective measure of activity with accelerometry
FitBit

Secondary Outcome Measures

Kilocalories/week assessed by Subjective measure of activity by self-report
Function/disability assessed by objective and subjective reports of functional ability

Full Information

First Posted
June 2, 2015
Last Updated
June 19, 2019
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02464254
Brief Title
Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE)
Acronym
INSPIRE
Official Title
Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Illnesses
Keywords
Physical activity, positive affect, older adults, aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity plus positive affect
Arm Type
Experimental
Arm Description
Subjects will be randomized to a physical activity goal and the positive affect component
Arm Title
Physical activity plus education
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to a physical activity goal and education
Intervention Type
Behavioral
Intervention Name(s)
Physical activity plus positive affect
Intervention Description
Subjects will be randomized to a physical activity goal and will receive the positive affect component.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity plus education
Intervention Description
Subjects will be randomized to a physical activity goal and will receive the educational component.
Primary Outcome Measure Information:
Title
Kilocalories/week assessed by Objective measure of activity with accelerometry
Description
FitBit
Time Frame
baseline to 12 months
Secondary Outcome Measure Information:
Title
Kilocalories/week assessed by Subjective measure of activity by self-report
Time Frame
baseline to 12 months
Title
Function/disability assessed by objective and subjective reports of functional ability
Time Frame
baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janey Peterson, EdD MS RN
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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