NCT00435188

Brief Summary

The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans. The primary physical performance outcome is change in gait speed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

January 9, 2015

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

3.4 years

First QC Date

February 12, 2007

Results QC Date

October 7, 2014

Last Update Submit

January 8, 2015

Conditions

AgingMobility Limitations

Keywords

AgingCost analysisCounselingDisabled PersonsHealth PromotionMobility LimitationPhysical ActivityPrimary CareRandomized Clinical TrialVeterans

Outcome Measures

Primary Outcomes (6)

  • Usual Gait Speed

    Best of two trials over 8-foot walk

    Baseline

  • Usual Gait Speed

    3 month

  • Usual Gait Speed

    12-month

  • Rapid Gait Speed

    Baseline

  • Rapid Gait Speed

    3-month

  • Rapid Gait Speed

    12-month

Secondary Outcomes (12)

  • Physical Activity Frequency (CHAMPS Questionnaire)

    Baseline

  • Physical Activity Frequency (CHAMPS Questionnaire)

    3 month

  • Physical Activity Frequency (CHAMPS Questionnaire)

    12 month

  • Self Rated Health

    Baseline

  • Self Rated Health

    3 month

  • +7 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL

Behavioral: Multi-component physical activity counseling program A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback

Behavioral: Multi-component physical activity counseling program

Arm 2

NO INTERVENTION

Usual care

Interventions

Multi-component physical activity counseling programBEHAVIORAL

A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback

Arm 1

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 70 or over
  • Followed in VA primary care or geriatrics clinic
  • Currently not regularly physically active
  • Able to walk 10 meters without human assistance (assistive device acceptable)

You may not qualify if:

  • Age 70 or over
  • Followed in VA primary care or geriatrics clinic
  • Currently not regularly physically active
  • Able to walk 10 meters without human assistance (assistive device acceptable)
  • A terminal diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (10)

  • Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39. doi: 10.1002/pon.1491.

    PMID: 19117329BACKGROUND

  • Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.

    PMID: 19436015BACKGROUND

  • Morey MC, Peterson MJ, Pieper CF, Sloane R, Crowley GM, Cowper P, McConnell E, Bosworth H, Ekelund C, Pearson M, Howard T. Project LIFE--Learning to Improve Fitness and Function in Elders: methods, design, and baseline characteristics of randomized trial. J Rehabil Res Dev. 2008;45(1):31-42. doi: 10.1682/jrrd.2007.03.0044.

    PMID: 18566924RESULT

  • Morey MC, Peterson MJ, Pieper CF, Sloane R, Crowley GM, Cowper PA, McConnell ES, Bosworth HB, Ekelund CC, Pearson MP. The Veterans Learning to Improve Fitness and Function in Elders Study: a randomized trial of primary care-based physical activity counseling for older men. J Am Geriatr Soc. 2009 Jul;57(7):1166-74. doi: 10.1111/j.1532-5415.2009.02301.x. Epub 2009 May 8.

    PMID: 19467149RESULT

  • Hall KS, Crowley GM, McConnell ES, Bosworth HB, Sloane R, Ekelund CC, Morey MC. Change in goal ratings as a mediating variable between self-efficacy and physical activity in older men. Ann Behav Med. 2010 Jun;39(3):267-73. doi: 10.1007/s12160-010-9177-5.

    PMID: 20387023RESULT

  • Huffman KM, Sloane R, Peterson MJ, Bosworth HB, Ekelund C, Pearson M, Howard T, Pieper CF, Morey MC. The impact of self-reported arthritis and diabetes on response to a home-based physical activity counselling intervention. Scand J Rheumatol. 2010 May;39(3):233-9. doi: 10.3109/03009740903348973.

    PMID: 20429674RESULT

  • Huffman KM, Hall KS, Sloane R, Peterson MJ, Bosworth HB, Ekelund C, Pearson M, Howard T, Pieper CF, Morey MC. Is diabetes associated with poorer self-efficacy and motivation for physical activity in older adults with arthritis? Scand J Rheumatol. 2010;39(5):380-6. doi: 10.3109/03009741003605630.

    PMID: 20604671RESULT

  • Hall KS, Crowley GM, Bosworth HB, Howard TA, Morey MC. Individual progress toward self-selected goals among older adults enrolled in a physical activity counseling intervention. J Aging Phys Act. 2010 Oct;18(4):439-50. doi: 10.1123/japa.18.4.439.

    PMID: 20956844RESULT

  • Hall KS, Sloane R, Pieper CF, Peterson MJ, Crowley GM, Cowper PA, McConnell ES, Bosworth HB, Ekelund CC, Morey MC. Long-term changes in physical activity following a one-year home-based physical activity counseling program in older adults with multiple morbidities. J Aging Res. 2010 Dec 26;2011:308407. doi: 10.4061/2011/308407.

    PMID: 21234104RESULT

  • Lum H, Sloane R, Huffman KM, Kraus VB, Thompson DK, Kraus WE, Bain JR, Stevens R, Pieper CF, Taylor GA, Newgard CB, Cohen HJ, Morey MC. Plasma acylcarnitines are associated with physical performance in elderly men. J Gerontol A Biol Sci Med Sci. 2011 May;66(5):548-53. doi: 10.1093/gerona/glr006. Epub 2011 Mar 2.

    PMID: 21367961RESULT

Related Links

MeSH Terms

Conditions

Mobility LimitationMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Miriam C. Morey, Ph.D.
Organization
Durham VA Research and Development
miriam.morey@va.gov
919-286-0411

Study Officials

  • Miriam C. Morey, PhD

    VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 14, 2007

Study Start

November 1, 2004

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

January 9, 2015

Results First Posted

January 9, 2015

Record last verified: 2015-01

Locations

US(1)