Clinical trial NCT01751685: Study of Hyperkyphosis, Exercise and Function-SHEAF
Official title: Study of Hyperkyphosis, Exercise and Function-SHEAF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kyphosis
Keywords: kyphosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-12-18
Enrollment: 99
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 60 years and older, kyphosis angle \>= 40 degrees measured by kyphometer, medical approval from study physician and primary care provider to participate in exercise intervention

Exclusion Criteria:

* Gait speed \<0.6 meters/sec, inability to rise from a chair with arms crossed at chest, painful vertebral fractures in the past 3 months, 3 or more falls in the past year, advanced disability or end-stage disease, major psychiatric illness, cognitive impairment, alcohol, drug abuse, or narcotic pain medications, uncontrolled hypertension, peripheral neuropathy associated with type I diabetes, chest pain, myocardial infarction, or cardiac surgery within the previous 6 months, diagnosed vestibular or neurologic disorder, total hip or knee replacement or hip fracture within previous 6 months, oral glucocorticoid medications for ≥ 3 months the past year, no active movement in thoracic spine, unable to execute exercise safety tests, failure to comply with run-in procedures: poor attendance, or use of actigraph, non-English speaking

Primary outcomes:
measure: Change in Cobb Angle of Kyphosis
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Modified Physical Performance Test (PPT)
timeFrame: Baseline and 6 months
Other outcomes:
measure: Effect of Exercise Intervention on Kyphosis
timeFrame: 1 year post baseline
measure: Effect of Exercise Intervention on Secondary Measure of Physical Function
timeFrame: 1-year post baseline
measure: Effect of Exercise Intervention on Health Related Quality of Life (HRQOL)
timeFrame: 6 month post baseline
measure: Effect of Exercise Intervention on Health Related Quality of Life (HRQOL)
timeFrame: 1 year post baseline
measure: Effect of Exercise Intervention on Muscle Strength
timeFrame: 6 month post baseline
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Wendy B Katzman, DPTSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katzman WB, Vittinghoff E, Kado DM, Schafer AL, Wong SS, Gladin A, Lane NE. Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol of a Randomized Controlled Trial of Multimodal Spine-Strengthening Exercise in Older Adults With Hyperkyphosis. Phys Ther. 2016 Mar;96(3):371-81. doi: 10.2522/ptj.20150171. Epub 2015 Aug 6.
citation: Katzman WB, Vittinghoff E, Lin F, Schafer A, Long RK, Wong S, Gladin A, Fan B, Allaire B, Kado DM, Lane NE. Targeted spine strengthening exercise and posture training program to reduce hyperkyphosis in older adults: results from the study of hyperkyphosis, exercise, and function (SHEAF) randomized controlled trial. Osteoporos Int. 2017 Oct;28(10):2831-2841. doi: 10.1007/s00198-017-4109-x. Epub 2017 Jul 8.