Evidence map›Paper›PMID 24786946›Full record

Trial reportPhysical therapy2014

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.

Lora M Giangregorio, Lehana Thabane, Jonathan D Adachi, Maureen C Ashe, Robert R Bleakney, E Anne Braun, Angela M Cheung, Lisa-Ann Fraser, Jenna C Gibbs, Keith D Hill and 7 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Physical therapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Exercise for improving outcomes after osteoporotic vertebral fracture.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Trial
  3. Describing the resource utilisation and costs associated withvertebral fractures: the Build Better Bones with Exercise (B3E) Pilot Trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2020
    Trial
  4. Trial
  5. 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.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2018
    Trial
  6. International consensus on the non-pharmacological and non-surgical management of osteoporotic vertebral fractures.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023
    Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Lora M GiangregorioL.M. Giangregorio, PhD, Department of Kinesiology, University of Waterloo, 200 University Ave W, Waterloo, Ontario, Canada N2L 3G1; Toronto Rehabilitation Institute-University Health Network, Toronto, Ontario, Canada; and Schlegel-UW Research Institute for Aging, Kitchener, Ontario, Canada. lora.giangregorio@uwaterloo.ca.
Lehana ThabaneL. Thabane, PhD, Clinical Epidemiology and Biostatistics, System Linked Research Unit on Health and Social Service Utilization (SLRU), Population Health Research Institute (PHRI), Hamilton Health Sciences, and Departments of Pediatrics and Anesthesia, McMaster University, Hamilton, Ontario, Canada; and Biostatistics Unit and Centre for Evaluation of Medicines, St Joseph's Healthcare, Hamilton, Ontario, Canada.
Jonathan D AdachiJ.D. Adachi, MD, FRCPC, Department of Medicine, McMaster University.
Maureen C AsheM.C. Ashe, BScPT, PhD, Department of Family Practice, University of British Columbia, and Centre for Hip Health and Mobility, Vancouver, British Columbia, Canada.
Robert R BleakneyR.R. Bleakney, MB, BAO, BCh, Department of Medical Imaging, University of Toronto, Toronto, Ontario, Canada.
E Anne BraunE.A. Braun, MD, MSc, FRCPC, FACP, Department of Medicine, McMaster University.
Angela M CheungA.M. Cheung, MD, PhD, Departments of Medicine and Medical Imaging, University of Toronto.
Lisa-Ann FraserL-A. Fraser, MD, MSc, Department of Medicine, University of Western Ontario.
Jenna C GibbsJ.C. Gibbs, PhD, Department of Kinesiology, University of Waterloo.
Keith D HillK.D. Hill, PhD, School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, Perth, Western Australia, Australia.
Anthony B HodsmanA.B. Hodsman, MD, Department of Medicine, University of Western Ontario.
David L KendlerD.L. Kendler, MD, FRC(PC), Department of Medicine, University of British Columbia.
Nicole MittmannN. Mittmann, PhD, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Sadhana PrasadS. Prasad, MD, FRCP(C), Department of Medicine, McMaster University.
Samuel C SchererS.C. Scherer, MBBS, Broadmeadows Health Service, Northern Health, Melbourne, Australia.
John D WarkJ.D. Wark, MB, BS, PhD, Department of Medicine and Bone & Mineral Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville, Victoria, Australia.
Alexandra PapaioannouA. Papaioannou, MD, MSc, Clinical Epidemiology and Biostatistics and Department of Medicine, McMaster University.

Funding

Canadian Institutes of Health Research
6 · The paper itself

Abstract

backgroundOur goal is to conduct a multicenter randomized controlled trial (RCT) to investigate whether exercise can reduce incident fractures compared with no intervention among women aged ≥65 years with a vertebral fracture.

objectivesThis pilot study will determine the feasibility of recruitment, retention, and adherence for the proposed trial.

designThe proposed RCT will be a pilot feasibility study with 1:1 randomization to exercise or attentional control groups.

settingFive Canadian sites (1 community hospital partnered with an academic center and 4 academic hospitals or centers affiliated with an academic center) and 2 Australian centers (1 academic hospital and 1 center for community primary care, geriatric, and rehabilitation services).

participantsOne hundred sixty women aged ≥65 years with vertebral fracture at 5 Canadian and 2 Australian centers will be recruited.

interventionThe Build Better Bones With Exercise (B3E) intervention includes exercise and behavioral counseling, delivered by a physical therapist in 6 home visits over 8 months, and monthly calls; participants are to exercise ≥3 times weekly. Controls will receive equal attention. MEASUREMENTS: Primary outcomes will include recruitment, retention, and adherence. Adherence to exercise will be assessed via calendar diary. Secondary outcomes will include physical function (lower extremity strength, mobility, and balance), posture, and falls. Additional secondary outcomes will include quality of life, pain, fall self-efficacy, behavior change variables, intervention cost, fractures, and adverse events. Analyses of feasibility objectives will be descriptive or based on estimates with 95% confidence intervals, where feasibility will be assessed relative to a priori criteria. Differences in secondary outcomes will be evaluated in intention-to-treat analyses via independent Student t tests, chi-square tests, or logistic regression. The Bonferroni method will be used to adjust the level of significance for secondary outcomes so the overall alpha level is .05. LIMITATIONS: No assessment of bone mineral density will be conducted. The proposed definitive trial will require a large sample size.

conclusionsThe 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.

Indexed as

Accidental FallsAgedAustraliaCanadaCounselingExercise TherapyFeasibility StudiesFemaleHumansPain MeasurementPatient CompliancePilot ProjectsQuality of LifeSelf EfficacySingle-Blind MethodSpinal Fractures

Identifiers

PMID24786946
PMCPMC4155040

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.