Study of Hyperkyphosis, Exercise and Function-SHEAF

NCT01751685 | Completed Results DMC

• 2 other identifiers: P0046955R01AG041921-05
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Kyphosis

Keywords

kyphosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months

Secondary Outcomes (1)

• Change in Modified Physical Performance Test (PPT)

  Baseline and 6 months

Other Outcomes (5)

• Effect of Exercise Intervention on Kyphosis

  1 year post baseline

• Effect of Exercise Intervention on Secondary Measure of Physical Function

  1-year post baseline

• Effect of Exercise Intervention on Health Related Quality of Life (HRQOL)

  6 month post baseline

Study Arms (2)

Kyphosis-specific spinal exercises

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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.

Other: Control

Interventions

Kyphosis-specific spinal strengthening exercises BEHAVIORAL

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.

Kyphosis-specific spinal exercises

Control OTHER

monthly educational lectures on various topics

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

Related Publications (2)

• 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.

  PMID: 26251480 BACKGROUND

• 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.

  PMID: 28689306 RESULT

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Limitations and Caveats

A healthy community-based group of adults ≥60 years of age were recruited and individuals with comorbidities that could interfere with safe participation in a group exercise class were excluded. Blinding the participants and the instructors providing the intervention is not possible. Although such blinding is not uncommon in exercise trials, it was ensured that the investigators measuring kyphosis and performing the physical function testing are blinded to group allocation.

Results Point of Contact

• Title: Wendy Katzman, PT
• Organization: University of California, San Francisco

Wendy.Katzman@ucsf.edu

415-353-7598

Study Officials

• Wendy B Katzman, DPTSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 18, 2012
• Study Start: February 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: May 31, 2019
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2023-03

Locations

US (1)