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

NCT ID: NCT02464254

Last Updated: 2019-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Chronic Illnesses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Physical activity plus positive affect

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

Group Type EXPERIMENTAL

Physical activity plus positive affect

Intervention Type BEHAVIORAL

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

Physical activity plus education

Intervention Type BEHAVIORAL

Subjects will be randomized to a physical activity goal and will receive the educational component.

Physical activity plus education

Subjects will be randomized to a physical activity goal and education

Group Type ACTIVE_COMPARATOR

Physical activity plus education

Intervention Type BEHAVIORAL

Subjects will be randomized to a physical activity goal and will receive the educational component.

Interventions

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Physical activity plus positive affect

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

Intervention Type BEHAVIORAL

Physical activity plus education

Subjects will be randomized to a physical activity goal and will receive the educational component.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janey Peterson, EdD MS RN

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1K23AG042869-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1303013686

Identifier Type: -

Identifier Source: org_study_id

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