Build Better Bones With Exercise: Protocol for a Feasibility Study of a Multicenter Randomized Controlled Trial of 12 Months of Home Exercise in Women With a Vertebral Fracture

Giangregorio, Lora; Thabane, Lehana; Adachi, Jonathan D.; Ashe, Maureen C.; Bleakney, Robert; Braun, Ethan; Cheung, Angela M.; Fraser, Lisa Ann; Gibbs, Jenna C.; Hodsman, Anthony B.; Kendler, David L.; Mittmann, Nicole; Prasad, Smriti; Scherer, Samuel; Wark, John D.; Παπαϊωάννου, Αλεξάνδρα

doi:10.2522/ptj.20130625

Cited by 22 publications

(15 citation statements)

References 67 publications

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“…However, repetitive poor posture and excessive spinal flexion during activities of daily living could cause vertebral fractures, particularly when there has been a past vertebral fracture and or low bone mass, irrespective of the degree of kyphosis. Ongoing research is currently investigating the effects of exercise including spinal muscle strengthening on incident vertebral fractures in older adults with prevalent fractures [33]. …”

Section: Falls and Fracturesmentioning

confidence: 99%

Age-related hyperkyphosis: update of its potential causes and clinical impacts—narrative review

et al. 2016

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The present study aims to qualitatively review the contributing factors and health implications of age-related hyperkyphosis. We conducted a narrative review of observational and cohort studies describing the risk factors and epidemiology of hyperkyphosis from 1955 to 2016 using the following key words: kyphosis, hyperkyphosis, posture, age-related hyperkyphosis, kyphotic posture, aetiology and causes. This review included 77 studies. Approximately 60–70 % of the most severe hyperkyphosis cases have no evidence of underlying vertebral compression fractures. Other proposed factors contributing to hyperkyphosis are degenerative disc disease, weakness of back extensor muscles and genetic predisposition. Strength and endurance of back extensor muscles are very important for maintaining normal postural alignment. Recent evidence suggests that age-related hyperkyphosis is not equivalent to spinal osteoporosis. Due to the negative impact of hyperkyphosis on physical function, quality of life and mortality rates, physicians should focus not only on osteoporosis, but also on age-related postural changes. More research about the relationship between spinal morphology and modifiable factors, especially the structural and functional parameters of trunk muscles, could further illuminate our understanding and treatment options for hyperkyphosis.

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Section: Falls and Fracturesmentioning

confidence: 99%

Age-related hyperkyphosis: update of its potential causes and clinical impacts—narrative review

et al. 2016

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“…The full protocol for this two-arm, 1:1 pilot multi-centre, international, single-blinded parallel RCT has been previously described [27] (ClinicalTrials.gov registration NCT01761084). Briefly, the Build Better Bones with Exercise (B3E) trial recruited community-dwelling women over the age of 65 years with at least one radiographically-confirmed vertebral compression fracture of Genant [28] Grade II or higher who were randomized via computer algorithm, using permuted block sizes of two or four, into either the exercise intervention or an attention control group.…”

Section: Methodsmentioning

confidence: 99%

Build better bones with exercise (B3E pilot trial): results of a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in older women with vertebral fracture

et al. 2018

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“…For multicomponent interventions, the screening becomes more complex. Our recent trial of home exercise in women with vertebral fractures included balance training, posture training and resistance exercises, and daily aerobic physical activity; we excluded individuals with exercise participation ≥ 3 times per week that addressed ≥ 2 of the domains [ 14 ]. Based on the inclusion criteria, individuals who walked daily were eligible because they were only participating in one of the domains (i.e., daily aerobic physical activity), and a key focus of the intervention was resistance and balance training.…”

Section: Challenges To Physical Activity Researchmentioning

confidence: 99%

“…Compensatory strategies might include an attention control or an active control that is attractive to participants, with or without deception (e.g., tell participants the study is comparing two exercise interventions). For instance, Giangregorio et al and Suttanon et al made sure that the control group received the same number and duration of home visits and phone calls [ 9 , 14 ]. Patten et al made sure that all participants received identical evidence-based smoking cessation counseling and added exercise counseling in the intervention group [ 7 ].…”

Section: Challenges To Physical Activity Researchmentioning

confidence: 99%

“…Feasibility outcomes could include recruitment rate [ 5 – 8 , 14 ], consent rate [ 6 ], adherence to the physical activity intervention [ 5 – 8 , 14 ], study retention [ 7 , 8 , 14 ], adverse events [ 5 , 6 , 8 , 9 ], and participant experience or satisfaction [ 5 , 7 , 8 , 14 ]. The decision to move from a pilot/feasibility study to a full trial should be based on the feasibility objectives and not the secondary outcome measures.…”

Section: Challenges To Physical Activity Researchmentioning

confidence: 99%

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Pilot and feasibility studies in exercise, physical activity, or rehabilitation research

El-Kotob

Giangregorio

2018

Pilot Feasibility Stud

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BackgroundClinical trials of physical activity and rehabilitation interventions can be challenging. Pilot or feasibility studies can be conducted prior to a definitive randomized controlled trial (RCT), to improve the chances of conducting a high-quality RCT of a physical activity intervention.Main bodyPhysical activity interventions or trials present unique challenges at the population, intervention, comparator and outcome levels. At each level, we present guidance for researchers on the design considerations for pilot or feasibility studies of physical activity interventions. When it comes to defining study population, physical activity trials often exclude participants with certain health conditions or other characteristics (e.g., age, gender) because of uncertainty of the safety of the exercise intervention or presumed differences in responsiveness, at the expense of trial generalizability. A pilot trial could help investigators determine refined inclusion and exclusion criteria to balance safety, adequate recruitment, and generalizability. At the intervention level, because exercise can be a complex intervention, pilot trials allow investigators to evaluate participant adherence and instructor fidelity to the intervention and participant experience. At the comparator level, control group dissatisfaction and post-randomization drop-out can occur, because of the desire to be randomized to the exercise group, and the difficulty with blinding to group allocation; an active control or deception could be used. Finally, at the outcome level, there should be an emphasis on the pilot or feasibility outcomes such as recruitment rate, adherence to exercise, and retention or fidelity, than the efficacy of the exercise intervention.ConclusionPhysical activity and rehabilitation researchers can use pilot and feasibility studies to enhance the rigor of future trials, while also publishing the results of their pilot work to move the field forward. Researchers in this field are encouraged to use published reporting guidelines for pilot and feasibility studies and to consider the challenges discussed in this paper.

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Build Better Bones With Exercise: Protocol for a Feasibility Study of a Multicenter Randomized Controlled Trial of 12 Months of Home Exercise in Women With a Vertebral Fracture

Abstract: The viability of a large-scale exercise trial in women with vertebral fractures will be evaluated, as well as the effects of a home exercise program on important secondary outcomes.

Cited by 22 publications

References 67 publications

Age-related hyperkyphosis: update of its potential causes and clinical impacts—narrative review

Age-related hyperkyphosis: update of its potential causes and clinical impacts—narrative review

Build better bones with exercise (B3E pilot trial): results of a feasibility study of a multicenter randomized controlled trial of 12 months of home exercise in older women with vertebral fracture

Pilot and feasibility studies in exercise, physical activity, or rehabilitation research

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