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Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol of a Randomized Controlled Trial of Multimodal Spine-Strengthening Exercise in Older Adults With Hyperkyphosis

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. Objectives 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. Design The RCT is a parallel-group design, with 1:1 randomization to exercise and attentional control groups. Setting The study will be conducted at one primary site (one academic medical center partnered with one local community medical center). Participants One hundred men and women, aged ≥60 years, with thoracic kyphosis ≥40 degrees will be randomized. Intervention 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. Measurements 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. Limitations 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.