Study of Hyperkyphosis, Exercise and Function-SHEAF

NCT ID: NCT01751685

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-01
• Study Completion Date: 2019-05-31

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.

Conditions

Kyphosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Kyphosis-specific spinal strengthening exercises

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

monthly educational lectures on various topics

Interventions

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.

Intervention Type: BEHAVIORAL

Control

monthly educational lectures on various topics

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy B Katzman, DPTSc

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26251480 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28689306 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R01AG041921-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P0046955

Identifier Type: -

Identifier Source: org_study_id