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. 2019 Jul 5;2019(7):CD008618. doi: 10.1002/14651858.CD008618.pub3

Giangregorio 2018.

Methods Pilot feasibility study with 1:1 randomization
Participants Women aged 65 years or older with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited
Countries: Canada and Australia
Inclusion criteria: women, aged 65 years or older, have radiographic evidence of a nontraumatic fracture of at least 1 vertebrae between T4 and L4 (vertebrae compressed ≥ 25%)
Exclusion criteria: index vertebral fracture due to trauma, not able to communicate in English, on dialysis, receiving palliative care, current or prior cancer (except basal cell carcinoma), clinically significant kidney, liver, or intestinal disease, exercise participation ≥ 3 times per week that addressed ≥ 2 of 5 domains in the Build Better Bones With Exercise exercise prescription, progressive neurological disorder or progressive disorder likely to prevent study completion, unable to stand or walk with or without a gait aid, impaired capacity to give informed consent (positive Mini‐Cog score and cannot recall what they are being asked to do during the consent process), or contraindication to exercise as determined by a physician.
Interventions Experimental
Frequency: at least 3 times/week
Intensity: lower‐ and upper‐extremity strengthening: use body weight, the floor or wall, or a lightweight TheraBand exercise band as resistance‐ maximum resistance with which 10 repetitions can be completed with good form (10‐RM) and begin with 2 sets of 8 to 10 repetitions at 10‐RM; posture training: hold each position for 3 seconds and repeat 3 times; balance training: difficulty will be individually tailored; aerobic exercise: 5 to 8 on the Borg Rating of Perceived Exertion Scale
Time: at least one exercise from each domain; aerobic training: begin with 10‐30 minutes; duration is progressively increased
Type: Build Better Bones with Exercise exercise prescription, including exercises focused on lower and upper extremity strengthening, balance, posture, and endurance training, and the Motivation to Move Program (a behavioral counseling guide informed by motivating interviewing and the health action process approach)
Duration of intervention: 52 weeks
Supervisor: physical therapist
Supervision/Setting: biweekly phone calls and 4 home visits (first 2 months), and monthly phone calls and 2 home visits (after 2 months), home exercise
Progression of intensity: yes
Control: same number of home visits and phone calls as intervention group (equal attention) with physical therapist; focused on health and social discussion
Duration of follow‐up after baseline assessment: 52 weeks
Outcomes Primary outcomes: recruitment, retention, and adherence
Secondary outcomes: physical performance (lower extremity strength and balance), posture, falls, quality of life (disease‐specific, generic), pain, fall self‐efficacy, behavior change variables, intervention cost, fractures, and adverse events
Notes ClinicalTrials.gov identifier: NCT01761084