NCT00105781

Brief Summary

Aging veterans with functional impairments followed in primary care clinics were randomized to counseling for a walking plus strength exercise home-based exercise program or to health education by a nurse. Exercise participants attended 3 intervention sessions totaling about 100 minutes of contact with the nurse and a physical therapy assistant over 10 months. They were also asked to record walking and strength exercise on monthly calendars and received motivational automated phone messages. Education control patients discussed health topics of their choice with the nurse. Materials were based on National Institute of Aging materials currently available on the internet. After 10 months, the exercise participants reported more time spent in walking and strength exercise and accelerometer data indicated a greater increase in time spent in moderate or higher intensity activity per day. Participants who engaged in strength exercises improved more on functional fitness tests and quality of life after 10 months. Analyses from the cognitive sub-study remain incomplete.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

April 7, 2015

Status Verified

May 1, 2007

First QC Date

March 16, 2005

Last Update Submit

April 6, 2015

Conditions

Keywords

NursesTelephoneCounselingExercise

Outcome Measures

Primary Outcomes (1)

  • Minutes and days per week of walking and strength training exercise at 5 and 10

Secondary Outcomes (1)

  • Functional fitness tests, Accelerometer activity, Quality of Life, and Cognitive performance in sub-sample

Study Arms (1)

Arm 1

OTHER
Behavioral: Exercise counseling

Interventions

Arm 1

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred by primary care providers in VA primary care clinics. Interested and willing to try to increase physical activity. Some self-reported or observed impairments in physical function. Excluded if there are health conditions that make home-based exercise not appropriate. Observed or self-reported physical function impairment Able to walk for health Living independently in community Able to return to VA MedicalCenter for research visits Enrolled in primary care Access to telephone

You may not qualify if:

  • Any of these within 6 months: myocardial infarction, congestive heart failure, TIA or stroke, leg fracture, seizure, uncontrolled arrhythmia, unstable angina Uncontrolled diabetes, hypertension, dyslipidemia FEV1 less than 1.5 Any condition that provider believes would make unsupervised exercise unsafe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

Jacksonport, Arkansas, 39216, United States

Location

Related Publications (1)

  • Dubbert PM, Morey MC, Kirchner KA, Meydrech EF, Grothe K. Counseling for home-based walking and strength exercise in older primary care patients. Arch Intern Med. 2008 May 12;168(9):979-86. doi: 10.1001/archinte.168.9.979.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Patricia M. Dubbert, PhD

    G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2005

First Posted

March 17, 2005

Study Start

November 1, 2002

Study Completion

February 1, 2006

Last Updated

April 7, 2015

Record last verified: 2007-05

Locations