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 effects health status, physical mobility, and quality of life, but there is no standard protocol for treating 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 or attentional control groups. SETTING One primary site (1 academic medical center partnered with 1 local community medical center). PARTICIPANTS One hundred men and women aged ≥60 years with thoracic kyphosis ≥40° will be randomized. INTERVENTION The targeted multi-modal 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 with monthly calls from study coordinator to monitor physical activity and any adverse events. MEASUREMENTS 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 (the modified Physical Performance Test, Timed Up and Go, Time Loaded Standing, 4-meter walk, Six-minute walk) and health-related quality of life (SRS-30 self-image domain, PROMIS Global Health Index and Physical Function Index). 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° will be evaluated to determine whether targeted multi-modal spine strengthening exercise reduces hyperkyphosis in older adults, as well as improves important secondary outcomes of physical function and health-related quality of life.