Back to resultsStudy of Hyperkyphosis, Exercise and Function-SHEAF (sheaf)
Primary Purpose
Kyphosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kyphosis-specific spinal strengthening exercises
Control
Sponsored by
About this trial
This is an interventional treatment trial for Kyphosis focused on measuring kyphosis
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
Sites / Locations
- UCSF
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Kyphosis-specific spinal exercises
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Cobb Angle of Kyphosis
The primary outcome is change in kyphosis from baseline to 6 months, measured using the gold standard Cobb angle of kyphosis derived from standing lateral spine radiographs and a standardized protocol for thoracic kyphosis (T4-T12). The study team performed exploratory analyses using the centroid method for measuring Cobb angle from lateral spine radiograph and the Debrunner kyphometer external measurement of kyphosis. Participants stood barefoot with knees straight and arms supported at 90° of flexion; they were instructed to hold full inhalation for the duration of the scan. Measurements were made by a trained radiologist (BF) who read the radiographs paired by participant but blinded to group allocation. A greater Cobb angle indicates more kyphosis severity.
Secondary Outcome Measures
Change in Modified Physical Performance Test (PPT)
Modified Physical Performance Test (PPT) is a composite measure of physical function in aging adults: 50ft [15.2-m] floor walk, putting on and removing a laboratory coat, picking up a penny from the floor, standing up 5 times from a 40.6cm-high [16in-high] chair without the use of arms, lifting a 7-lb book to a shelf, climbing one flight of stairs, and standing with feet together) and 2 additional untimed tasks (climbing up and down 4 flights of stairs and performing a 360° turn).
The test involves 9 functional items, 4 points per item; the range is 0-36 points, and higher values represent a higher physical performance.
Full Information
NCT ID
NCT01751685
First Posted
December 3, 2012
Last Updated
March 6, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT01751685
Brief Title
Study of Hyperkyphosis, Exercise and Function-SHEAF
Acronym
sheaf
Official Title
Study of Hyperkyphosis, Exercise and Function-SHEAF
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
July 1, 2016 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kyphosis
Keywords
kyphosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kyphosis-specific spinal exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Kyphosis-specific spinal strengthening exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
monthly educational lectures on various topics
Primary Outcome Measure Information:
Title
Change in Cobb Angle of Kyphosis
Description
The primary outcome is change in kyphosis from baseline to 6 months, measured using the gold standard Cobb angle of kyphosis derived from standing lateral spine radiographs and a standardized protocol for thoracic kyphosis (T4-T12). The study team performed exploratory analyses using the centroid method for measuring Cobb angle from lateral spine radiograph and the Debrunner kyphometer external measurement of kyphosis. Participants stood barefoot with knees straight and arms supported at 90° of flexion; they were instructed to hold full inhalation for the duration of the scan. Measurements were made by a trained radiologist (BF) who read the radiographs paired by participant but blinded to group allocation. A greater Cobb angle indicates more kyphosis severity.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in Modified Physical Performance Test (PPT)
Description
Modified Physical Performance Test (PPT) is a composite measure of physical function in aging adults: 50ft [15.2-m] floor walk, putting on and removing a laboratory coat, picking up a penny from the floor, standing up 5 times from a 40.6cm-high [16in-high] chair without the use of arms, lifting a 7-lb book to a shelf, climbing one flight of stairs, and standing with feet together) and 2 additional untimed tasks (climbing up and down 4 flights of stairs and performing a 360° turn).
The test involves 9 functional items, 4 points per item; the range is 0-36 points, and higher values represent a higher physical performance.
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Effect of Exercise Intervention on Kyphosis
Description
Investigators will measure change in Cobb angle on lateral spine radiograph.
Time Frame
1 year post baseline
Title
Effect of Exercise Intervention on Secondary Measure of Physical Function
Description
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.
Time Frame
1-year post baseline
Title
Effect of Exercise Intervention on Health Related Quality of Life (HRQOL)
Description
Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires.
Time Frame
6 month post baseline
Title
Effect of Exercise Intervention on Health Related Quality of Life (HRQOL)
Description
Investigators will measure change in HRQOL with the Scoliosis Research Society SRS-30 (self image domain) and PROMIS Physical Function and Global Health questionnaires.
Time Frame
1 year post baseline
Title
Effect of Exercise Intervention on Muscle Strength
Description
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.
Time Frame
6 month post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy B Katzman, DPTSc
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26251480
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.
Results Reference
background
PubMed Identifier
28689306
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.
Results Reference
result
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Study of Hyperkyphosis, Exercise and Function-SHEAF
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