Study of Hyperkyphosis, Exercise and Function-SHEAF (sheaf)

This study is currently recruiting participants.
Verified January 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01751685
First received: December 3, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Kyphosis
Behavioral: Kyphosis-specific spinal strengthening exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Hyperkyphosis, Exercise and Function-SHEAF

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Effect of exercise intervention on kyphosis [ Time Frame: 6-mos post baseline ] [ Designated as safety issue: No ]
    Investigators will measure change in Cobb angle on lateral spine radiograph.


Secondary Outcome Measures:
  • Effect of exercise intervention on secondary measure of physical function [ Time Frame: 6 months post baseline ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Effect of exercise intervention on kyphosis [ Time Frame: 1 year post baseline ] [ Designated as safety issue: No ]
    Investigators will measure change in Cobb angle on lateral spine radiograph.

  • Effect of exercise intervention on secondary measure of physical function [ Time Frame: 1-year post baseline ] [ Designated as safety issue: No ]
    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.

  • Effect of exercise intervention on health related quality of life (HRQOL) [ Time Frame: 6 month post baseline ] [ Designated as safety issue: No ]
    Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires.

  • Effect of exercise intervention on health related quality of life (HRQOL) [ Time Frame: 1 year post baseline ] [ Designated as safety issue: No ]
    Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires.

  • Effect of exercise intervention on muscle strength [ Time Frame: 6 month post baseline ] [ Designated as safety issue: No ]
    Investigators will measure change in spinal muscle strength as measured with a Biodex computerized dynamometer, and spinal muscle density as measured with quantitative computed tomography.


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kyphosis-specific spinal exercises
Investigator developed the intervention protocol (Kyphosis-specific 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.
Behavioral: Kyphosis-specific spinal strengthening exercises
Investigator developed the intervention protocol (Kyphosis-specific spinal strengthening 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.
Placebo Comparator: Control
Usual care control group will meet once a month for educational lectures on various topics. At the end of 6 months, each control group participant will get a one-on-one session with the physical therapist who was leading the intervention classes.

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751685

Contacts
Contact: Shirley Wong, BS 415-514-6776 wongs@ptrehab@ucsf.edu

Locations
United States, California
UCSF Recruiting
San Francisco, California, United States, 94143
Contact: Wendy Katzman, PT DPTSc OCS    415-514-6776    wendy.katzman@ucsfmedctr.org   
Principal Investigator: Wendy Katzman, PT DPTSc OCS         
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01751685     History of Changes
Other Study ID Numbers: P0046955
Study First Received: December 3, 2012
Last Updated: January 16, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
kyphosis

Additional relevant MeSH terms:
Kyphosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 16, 2014