Study of Hyperkyphosis, Exercise and Function-SHEAF
| Status: | Active, not recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 6/22/2018 |
| Start Date: | February 2013 |
| End Date: | May 30, 2019 |
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.
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.
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.
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.
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
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