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

NCT02464254 | Unknown DMC

• 2 other identifiers: 13030136861K23AG042869-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Illnesses

Keywords

Physical activity, positive affect, older adults, aging

Outcome Measures

Primary Outcomes (1)

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

  FitBit

  baseline to 12 months

Secondary Outcomes (2)

• Kilocalories/week assessed by Subjective measure of activity by self-report

  baseline to 12 months

• Function/disability assessed by objective and subjective reports of functional ability

  baseline to 12 months

Study Arms (2)

Physical activity plus positive affect

EXPERIMENTAL

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

Behavioral: Physical activity plus positive affect; Behavioral: Physical activity plus education

Physical activity plus education

ACTIVE COMPARATOR

Subjects will be randomized to a physical activity goal and education

Behavioral: Physical activity plus education

Interventions

Physical activity plus positive affect BEHAVIORAL

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

Physical activity plus positive affect

Physical activity plus education BEHAVIORAL

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

Physical activity plus education; Physical activity plus positive affect

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Charlson Index greater or equal to 3

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Chronic Disease; Motor Activity

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Janey Peterson, EdD MS RN

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 8, 2015
• Study Start: April 1, 2016
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2020
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

US (1)