Overview

This trial is active, not recruiting.

Condition kyphosis
Treatment kyphosis spinal strengthening exercises
Sponsor University of California, San Francisco
Collaborator University of California, Davis
Start date February 2013
End date May 2016
Trial size 112 participants
Trial identifier NCT01766674, P0045190

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Investigator developed the intervention protocol (Kyphosis spinal exercises) of targeted spine exercises during our pilot study based upon the literature and clinical experience.We standardized the protocol with a written script and a video. Each exercise session will be preceded by light aerobic activity, ended with cool-down and stretching the neck, chest and all extremities. All participants will be carefully monitored to ensure that all exercises will be performed slowly, with correct body alignment and technique to minimize risk of injury.
kyphosis spinal strengthening exercises
Investigator developed the intervention protocol (Kyphosis spinal exercises) of targeted spine exercises during our pilot study based upon the literature and clinical experience.We standardized the protocol with a written script and a video. Each exercise session will be preceded by light aerobic activity, ended with cool-down and stretching the neck, chest and all extremities. All participants will be carefully monitored to ensure that all exercises will be performed slowly, with correct body alignment and technique to minimize risk of injury.
(No Intervention)
Control group will be enrolled in the usual care waitlist group

Primary Outcomes

Measure
Effect of exercise intervention on kyphosis
time frame: 3-month post baseline

Secondary Outcomes

Measure
Effect of exercise intervention on physical function
time frame: 3-month post baseline

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Specialized Centers of Research (SCOR) Kyphosis Study
Principal investigator Nancy E Lane, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.