Clinical trial NCT01766674: Specialized Centers of Research (SCOR)on Sex Differences - Kyphosis Study
Official title: Specialized Centers of Research (SCOR) Kyphosis Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kyphosis
Keywords: Kyphosis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of California, Davis
First posted: 2013-01-11
Enrollment: 112
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 description: 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 spine radiograph at the end of the intervention.

Both groups will receive a copy of the study exercise DVD at the end of the study.

Table 2. Exercise Intervention Exercises Spinal strengthening exercises (20 mins)10-12 repetitions at 70-80% 1RM Progress from 0 - 5# or theraband Spinal mobility exercises (10 mins) Passive 30 second hold Warm-up (10 mins) Increase core temperature with aerobic warm-up on bike/treadmill Prone trunk lift to neutral Spine mobilization on roller Quadruped arm/leg lift Standing shoulder flexion/thoracic extension Cool-down (5 mins) Bilateral latissimus pull-down on roller Quadruped thoracic extension mobilization Neck and upper extremity stretches Sidelying rotation and extension Spinal alignment (15 mins) Transversus abdominous strengthening Training in bilateral and single leg stance Lower extremity stretches Wall push-ups with spine in neutral Training sit-to stand, squats, lunges Diaphragmatic breathing

Eligibility criteria: Inclusion Criteria:

* 60 years and older
* kyphosis \>=40 degrees
* medical approval from primary care clinician

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: Effect of exercise intervention on kyphosis
timeFrame: 3-month post baseline
Secondary outcomes:
measure: Effect of exercise intervention on physical function
timeFrame: 3-month post baseline
Other outcomes:
measure: Effect of exercise intervention on health related quality of life (HRQOL)
timeFrame: 3-month post baseline
measure: Effect of exercise intervention on kyphosis
timeFrame: 6month post baseline for crossovers
measure: Effect of exercise intervention on physical function
timeFrame: 6month post baseline for crossovers
measure: Effect of exercise intervention on health related quality of life (HRQOL)
timeFrame: 6month post baseline for crossovers
measure: Difference in baseline characteristics and intervention effects in kyphosis in men and women
timeFrame: 3month post baseline
measure: Difference in baseline characteristics and intervention effects in kyphosis in men and women
timeFrame: 6month post baseline for crossovers
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Wendy Katzman, PT,DPTSc,OCS
role: STUDY_DIRECTOR
affiliation: UC Davis
name: Nancy E Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gladin A, Katzman WB, Fukuoka Y, Parimi N, Wong S, Lane NE. Secondary analysis of change in physical function after exercise intervention in older adults with hyperkyphosis and low physical function. BMC Geriatr. 2021 Feb 22;21(1):133. doi: 10.1186/s12877-021-02062-8.
citation: Katzman WB, Parimi N, Gladin A, Poltavskiy EA, Schafer AL, Long RK, Fan B, Wong SS, Lane NE. Sex differences in response to targeted kyphosis specific exercise and posture training in community-dwelling older adults: a randomized controlled trial. BMC Musculoskelet Disord. 2017 Dec 4;18(1):509. doi: 10.1186/s12891-017-1862-0.