Clinical Trial: Study of Hyperkyphosis, Exercise and Function-SHEAF

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

Official Title: Study of Hyperkyphosis, Exercise and Function-SHEAF

Brief Summary: We propose to conduct a randomized, controlled trial among 100 men and women aged 60 or older with hyperkyphosis to an exercise intervention that includes kyphosis-specific spinal muscle strengthening exercises compared to a usual care control group. The study will be conducted in five waves,with 10 participants in the exercise intervention and 10 participants in the control group in each wave.

Detailed Summary: The experimental interventions will be provided in small groups meeting three sessions per week for 6 months. At baseline and 6 months after the intervention, we will measure kyphosis, physical function, spine muscle strength and density, and quality of life. We will assess the effect of the intervention on the co-primary outcomes of kyphosis, modified Physical Performance Test (PPT) and gait speed measured as change over 6 months. We will also assess the effect of the intervention on secondary outcomes of physical function and health-related quality of life, measured as change in Timed Up and Go, Timed Loaded Standing, Six-Minute Timed Walk, the Scoliosis Research Society SRS-30, PROMISe Global Health and physical function and PACE questionnaires. Furthermore, we will investigate whether changes in kyphosis, spinal muscle strength and/or density mediate the effect of the intervention on change in physical function. After the 6-month intervention, both groups will continue their usual activity and we will assess the durability of the effects of the intervention at 1-year follow-up.
Sponsor: University of California, San Francisco

Current Primary Outcome: Effect of exercise intervention on kyphosis [ Time Frame: 6-mos 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 secondary measure of physical function [ Time Frame: 6 months 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: December 3, 2012
Date Started: February 2013
Date Completion: June 2017
Last Updated: October 25, 2016
Last Verified: October 2016