Build Better Bones With Exercise

NCT01761084 | Completed Results DMC

• 1 other identifier: 18539
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%.

Conditions

Osteoporotic Fractures; Spinal Fractures

Keywords

Osteoporosis; Spine fracture; Vertebral fracture; Exercise Interventions; Exercise

Outcome Measures

Primary Outcomes (2)

• Feasibility of Recruitment and Retention

  Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.

  Monthly records up to 12 months.

• Adherence

  Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence.

  Monthly records over 12 months

Secondary Outcomes (22)

• Number of Fractures.

  Baseline, one year and at report of fracture (monitored monthly for reports).

• Number of Fallers

  Monthly up to one year.

• Occiput to Wall Distance

  Baseline and one year.

• Scores on the Short Physical Performance Battery (SPPB)

  Baseline and one year.

• Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).

  Baseline and one year.

Study Arms (2)

Exercise and behaviour change strategies

EXPERIMENTAL

The exercise program will include strength training, balance training and cardiovascular exercise that is individually tailored to the participants' abilities. The physical therapist will also implement strategies to assist with behaviour change, such as documenting progress in a log, participating in action planning and coping planning, and using techniques in the spirit of motivational interviewing.

Behavioral: Exercise and behaviour change strategies

General health or social discussion

NO INTERVENTION

Participants in the control group will receive equal attention, but will not be prescribed exercise, or participate in counselling about exercise. The physical therapist will discuss topics related to general health.

Interventions

Exercise and behaviour change strategies BEHAVIORAL

1. cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day 2. postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily) 3. perform muscle strengthening and balance training exercises ≥ 3 days a week 4. the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day.

Exercise and behaviour change strategies

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Has a) a known or suspected vertebral fracture of non-traumatic etiology OR b) one of the following:
• documented height loss of ≥2cm
• historical height loss of ≥6cm
• visible hyperkyphosis
• age greater than or equal to 65 years of age
• able to understand instructions in english
• able to give informed consent (no cognitive impairment)

You may not qualify if:

• Current or prior cancer
• On dialysis, known liver, kidney or malabsorption disease
• Progressive neurological disorder, unable to stand or walk for 10 metres, with/without gait aid or progressive disorder likely to prevent study completion, palliative care.
• Current participation in muscle strengthening or similar exercise program ≥ 3 times per week
• Uncontrolled hypertension or other contraindications to exercise

Sponsors & Collaborators

• University of Waterloo: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of Western Ontario, Canada: collaborator
• University Health Network, Toronto: collaborator
• McMaster University: collaborator
• University of Melbourne: collaborator
• University of British Columbia: collaborator

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

Related Publications (2)

• Gibbs JC, McArthur C, Wark JD, Thabane L, Scherer SC, Prasad S, Papaioannou A, Mittmann N, Laprade J, Kim S, Khan A, Kendler DL, Hill KD, Cheung AM, Bleakney R, Ashe MC, Adachi JD, Giangregorio LM. The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial. Phys Ther. 2020 Apr 17;100(4):662-676. doi: 10.1093/ptj/pzz188.

  PMID: 31899499 DERIVED

• Giangregorio LM, Thabane L, Adachi JD, Ashe MC, Bleakney RR, Braun EA, Cheung AM, Fraser LA, Gibbs JC, Hill KD, Hodsman AB, Kendler DL, Mittmann N, Prasad S, Scherer SC, Wark JD, Papaioannou A. 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. Phys Ther. 2014 Sep;94(9):1337-52. doi: 10.2522/ptj.20130625. Epub 2014 May 1.

  PMID: 24786946 DERIVED

Related Links

• Principal Investigator

MeSH Terms

Conditions

Osteoporotic Fractures; Spinal Fractures; Osteoporosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Spinal Injuries; Back Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Lora Giangregorio
• Organization: University of Waterloo

lmgiangr@uwaterloo.ca

5198884567

Study Officials

• Lora Giangregorio, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 4, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 14, 2019
• Results First Posted: November 14, 2019

Record last verified: 2017-03

Locations

CA (1)