title: Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol of a Randomized Controlled Trial of Multimodal Spine-Strengthening Exercise in Older Adults With Hyperkyphosis.
abstract: BACKGROUND
  Hyperkyphosis negatively affects health status, physical mobility, and quality of life, but there is no standard protocol for treating people with hyperkyphosis. Treatment options include targeted exercise.
  
  
  OBJECTIVE
  This single-site randomized controlled trial (RCT) will determine the efficacy of a targeted multimodal spine-strengthening exercise program, compared with no exercise intervention, among community-dwelling men and women aged ≥60 years.
  
  
  METHODS
  The RCT is a parallel-group design, with 1:1 randomization to exercise and attentional control groups.
  
  
  METHODS
  The study will be conducted at one primary site (one academic medical center partnered with one local community medical center).
  
  
  METHODS
  One hundred men and women, aged ≥60 years, with thoracic kyphosis ≥40 degrees will be randomized.
  
  
  METHODS
  The targeted multimodal spine-strengthening exercise intervention includes exercise and postural training delivered by a physical therapist in a group of 10 participants, 3 times a week for 6 months. Controls receive monthly health education meetings in a group of 10 participants and monthly calls from the study coordinator to monitor physical activity and any adverse events.
  
  
  METHODS
  The primary outcome is change in Cobb angle of kyphosis measured from lateral spine radiographs at baseline and 6 months. Secondary outcomes include change in physical function (assessed with the modified Physical Performance Test, Timed "Up & Go" Test, timed loaded standing, 4-m walk, and Six-Minute Walk Test) and health-related quality of life (assessed with the modified Scoliosis Research Society instrument [SRS-30] self-image domain and Patient Reported Outcomes Measurement Information System [PROMIS] global health and physical function indexes). Additional secondary outcomes include pain, physical activity level, spinal flexion and extension muscle strength, paraspinal extensor muscle density, and adverse events.
  
  
  CONCLUSIONS
  Blinding of the participants and instructors providing the intervention is not possible.
  
  
  CONCLUSIONS
  The efficacy of a high-quality, adequately powered exercise intervention in men and women with kyphosis ≥40 degrees will be evaluated to determine whether targeted multimodal spine-strengthening exercise reduces hyperkyphosis in older adults and improves important secondary outcomes of physical function and health-related quality of life.
authors.affiliation: W.B. Katzman, PT, DPTSc, OCS, Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco, UCSF Box 0625, San Francisco, CA 94143-0625 (USA). wendy.katzman@ucsf.edu.
authors.forename: Wendy B
authors.initials: WB
authors.lastname: Katzman
authors.affiliation: E. Vittinghoff, PhD, Department of Epidemiology and Biostatistics, University of California, San Francisco.
authors.forename: Eric
authors.initials: E
authors.lastname: Vittinghoff
authors.affiliation: D.M. Kado, MD, MS, Departments of Family Medicine and Public Health and Internal Medicine, University of California, San Diego, California.
authors.forename: Deborah M
authors.initials: DM
authors.lastname: Kado
authors.affiliation: A.L. Schafer, MD, Department of Epidemiology and Biostatistics and Department of Medicine, University of California, San Francisco, and Medical Service, San Francisco Veterans Affairs Medical Center, San Francisco, California.
authors.forename: Anne L
authors.initials: AL
authors.lastname: Schafer
authors.affiliation: S.S. Wong, BS, Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco.
authors.forename: Shirley S
authors.initials: SS
authors.lastname: Wong
authors.affiliation: A. Gladin, PT, MPT, DPT, OCS, Kaiser Permanente Northern California, San Francisco Medical Center, San Francisco, California.
authors.forename: Amy
authors.initials: A
authors.lastname: Gladin
authors.affiliation: N.E. Lane, MD, Department of Internal Medicine, University of California, Davis, Davis, California.
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Lane
mesh_terms: D000368:Aged; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D007738:Kyphosis / Q000503:physiopathology* / Q000534:rehabilitation*; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D016896:Treatment Outcome