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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00097643
Other study ID # AG0009
Secondary ID 5R01AG014777-05
Status Completed
Phase Phase 3
First received November 24, 2004
Last updated August 12, 2008
Start date September 2000
Est. completion date September 2004

Study information

Verified date August 2008
Source National Institute on Aging (NIA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the relative and combined efficacy of a physical activity and health promotion program to help sedentary adults over age 70 maintain an independent life style.


Description:

The study recruited 273 participants from a community-based HMO for whom computerized health service utilization and cost data were already available, as well as cognitive, functional, and health status measures. The participants were randomly placed into one of four treatment groups: exercise, health promotion, combination exercise and health promotion, and routine medical care. Assessments for physical performance, emotional well-being, and physical and emotional health status were conducted at screening, baseline, after 3 months (post-treatment), and at 6, 12, and 18-month follow-up by interviewers blind to treatment assignment.


Recruitment information / eligibility

Status Completed
Enrollment 273
Est. completion date September 2004
Est. primary completion date September 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 70 Years and older
Eligibility Inclusion Criteria:

- age 70 or older

- live independently

- less than 150 minutes regular exercise per week

- able to walk across a room without a person assisting

- English speaking

- planning to stay in local area for at least 6 months (duration of active study)

Exclusion Criteria:

- cancer

- heart attack

- stroke

- uncontrolled arrhythmia

- uncontrolled hypertension

- uncontrolled diabetes

- surgery during the past year

- ongoing mental health or psychiatric condition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
exercise

health promotion


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Aging (NIA)

References & Publications (7)

King AC, Pruitt LA, Phillips W, Oka R, Rodenburg A, Haskell WL. Comparative effects of two physical activity programs on measured and perceived physical functioning and other health-related quality of life outcomes in older adults. J Gerontol A Biol Sci Med Sci. 2000 Feb;55(2):M74-83. — View Citation

Nelson ME, Layne JE, Bernstein MJ, Nuernberger A, Castaneda C, Kaliton D, Hausdorff J, Judge JO, Buchner DM, Roubenoff R, Fiatarone Singh MA. The effects of multidimensional home-based exercise on functional performance in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Feb;59(2):154-60. — View Citation

Schulz R, Heckhausen J. A life span model of successful aging. Am Psychol. 1996 Jul;51(7):702-14. — View Citation

Seeman TE, Charpentier PA, Berkman LF, Tinetti ME, Guralnik JM, Albert M, Blazer D, Rowe JW. Predicting changes in physical performance in a high-functioning elderly cohort: MacArthur studies of successful aging. J Gerontol. 1994 May;49(3):M97-108. — View Citation

Strawbridge WJ, Cohen RD, Shema SJ, Kaplan GA. Successful aging: predictors and associated activities. Am J Epidemiol. 1996 Jul 15;144(2):135-41. — View Citation

Strawbridge WJ, Deleger S, Roberts RE, Kaplan GA. Physical activity reduces the risk of subsequent depression for older adults. Am J Epidemiol. 2002 Aug 15;156(4):328-34. — View Citation

Stuck AE, Walthert JM, Nikolaus T, Büla CJ, Hohmann C, Beck JC. Risk factors for functional status decline in community-living elderly people: a systematic literature review. Soc Sci Med. 1999 Feb;48(4):445-69. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary physical health and function screening, baseline, 3, 6, 12, and 18 months No
Primary affective status screening, baseline, 3, 6, 12, and 18 months No
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