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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00037167
Other study ID # R44AR048029
Secondary ID NIAMS-071
Status Completed
Phase Phase 1/Phase 2
First received May 16, 2002
Last updated April 8, 2009
Start date September 2001
Est. completion date April 2007

Study information

Verified date April 2009
Source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study uses a patented type of exercise poles, developed to assist runners rehabilitating from lower body injuries. These poles may offer older adults improved stability, reduced fear of falling, and lessened lower body pain when exercise walking.


Description:

Phase 1 (being concluded as of Feb 2002) used 18 older adults to investigate prototype versions of the running poles. Preliminary results, after 3 months of testing, indicate the poles are safe and effective. Phase 2 will use improved versions of the poles, which are currently in development, with a group of around 125-150 subjects over a longer length of time (12 months). Changes in walking gait quality, balance, strength, body composition, exercise adherence, and subjective perceptions of wellness will be assessed before, during, and after the 12 month exercise session.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 80 Years
Eligibility Inclusion Criteria:

- Age 65-80

- Normal gait

Exclusion Criteria:

- Inability to walk continuously for 5 minutes

- Contraindication from a personal physician

- Height over 6'2" or weight over 200 lbs (due to limitations of existing pole design)

- Mild to severe cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Exercise poles


Locations

Country Name City State
United States School of Physical Education, Biomechanics Lab Muncie Indiana

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Ball State University

Country where clinical trial is conducted

United States, 

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