Clinical Trial: Specialized Centers of Research (SCOR)on Sex Differences - Kyphosis Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Specialized Centers of Research (SCOR) Kyphosis Study

Brief Summary: This is a randomized, controlled trial among 100 total males and females with hyperkyphosis, aged 60 years and older, to determine the effects of an exercise intervention that includes high intensity spinal muscle strengthening exercises compared to a usual care waitlist group.

Detailed Summary:

Participants assigned to the intervention group will receive a high-intensity spinal strengthening group exercise program for 1 hour twice per week for 12 weeks, with home practice. The exercise program is outlined below in Table 2. The participants assigned to the control group will be receive usual care and be enrolled in a waitlist group. A physical therapist will teach the high-intensity spine strengthening exercise intervention sessions. Additionally, physical therapy graduate students will attend all exercise sessions to help ensure the safety of all participants and maintain a ratio of no more than five participants to one teacher. Participants in the control group will crossover to the spinal strengthening exercise group after 12 weeks and receive the intervention for 12 weeks.

All potential participants will be screened initially with a medical screening exam, and their primary care provider will be contacted by the study physician for approval for study participation. The participant will sign the medical release giving their primary care provider permission to release medical information to the study physician. The primary outcome will be change in Cobb angle of kyphosis over 12 weeks calculated from measurements taken from lateral spine radiographs and change in the Physical Performance Test (PPT). The investigators will also assess the effect of the exercise intervention on the secondary outcomes of physical function, strength and quality of life. The investigators will also use dual-energy x-ray absorptiometry (DXA) to determine bone mineral density before the study intervention. Study participants will receive an actigraph to measure physical activity throughout the study.

For participants in the control group who crossover to the exercise intervention group at 12 weeks will receive an additional lateral spi
Sponsor: University of California, San Francisco

Current Primary Outcome: Effect of exercise intervention on kyphosis [ Time Frame: 3-month post baseline ]

Investigators will measure change in Cobb angle on lateral spine radiograph.


Original Primary Outcome: Same as current

Current Secondary Outcome: Effect of exercise intervention on physical function [ Time Frame: 3-month post baseline ]

Investigators will measure change in physical function with Modified Physical Performance Test (PPT), gait speed, Timed Up and Go, Timed Loaded Standing, 6 minute walk and spinal extensor muscle strength


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: January 9, 2013
Date Started: February 2013
Date Completion: June 2017
Last Updated: October 25, 2016
Last Verified: October 2016