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ACTIVE NOT RECRUITING

NCT05927623

Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

View on ClinicalTrials.gov

Summary

Men sustain over one-third of osteoporosis-related fractures worldwide. The burden of osteoporotic fractures in older men is substantial, and men suffer significantly worse fracture-related outcomes than women. Following a fracture, men sustain greater rates of subsequent fractures, loss of autonomy, and mortality than women and the imminent risk of re-fracture is several times higher in men than in women. Functional mobility, known to predict falls and fractures, is also notably worse in men following a fracture. In the fiscal year 2007-08, the overall annual costs of osteoporosis in Canadian men was evaluated to be $910 million. Osteoporosis is primarily considered a disease of older women, and men are remarkably under-evaluated and under-treated for it. Recognition of sex and gender influences on skeletal health in men has been very slow; akin to the gap in cardiovascular diseases, where women are far less likely to receive guideline-recommended investigations and treatment. Over 85% of Canadian men who suffer from fragility fractures do not receive osteoporosis screening and/or treatment strategies. The existence of this care gap in men underscores our current struggle to overcome important barriers including: 1) men's lack of awareness of the critical impact of osteoporosis and fractures on several aspects of their lives, and of the benefits of treatment; and 2) the absence of comprehensive and accessible treatments tailored to men. Informed by the Knowledge-to-Action framework, we aim to address these barriers by adapting interventions with proven efficacy to engage men at high fracture risk in health behaviour change. The current protocol is for a pilot RCT to determine the feasibility of recruitment and retention, adherence to, and acceptability of the virtually-delivered fracture prevention intervention only. Our long-term goal is to conduct a large pragmatic randomized controlled trial (RCT) to address the research question: In older adults at high risk for fractures who self-identify as men, does anti-osteoporosis pharmacotherapy in conjunction with a virtually-delivered intervention that includes a gender-tailored strength training and balance based exercise program and nutritional counselling, improve functional mobility compared to anti-osteoporosis pharmacotherapy in conjunction with an attention control intervention.

Official title: Multifaceted Intervention Using Telehealth to Reduce the Risk of Falls and Fractures in Older Men (MisterFit): A Pilot Study

Key Details

Gender

MALE

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-02-07

Completion Date

2026-03-31

Last Updated

2025-07-20

Healthy Volunteers

Conditions

Osteoporosis Osteoporotic Fractures Osteoporosis, Age-Related Muscle Loss Men Aging

Interventions

BEHAVIORAL

Multifaceted Virtual Fracture Prevention Program

* Personalized exercise prescription: Comprised of muscle strengthening and balance exercises to perform three times a week, delivered and monitored remotely via the MisterFit app, a branded version of the secure commercially available Wibbi app (wibbi.com) and monthly virtual exercise consultations. * Virtual nutrition counseling from a registered dietitian in months 2, 4 and 6: to encourage participants to meet daily targets for calcium and vitamin D (preferably from diet), and protein intake to support muscle accretion and target weight maintenance * Virtual interactive information sessions in month 4 and 8: to education participants on topics identified as important by the Misterfit patient partner advisory committee.

BEHAVIORAL

Attention Control

* Encouraged to meet the 24-Hour Movement Guidelines for adults aged 65 years or older (https://csepguidelines.ca) with telephone contacts at the same frequency that the Misterfit online group receives virtual exercise consultations * Nutritional fact sheets: sent by e-mail at the same frequency that the Misterfit online group meets with the research dietitian. * Educational fact sheets: sent by e-mail at the same frequency that the Misterfit Online group has virtual interactive information sessions

Community-dwelling individuals ≥ 60 years who self-identify as men will be considered eligible if their risk for fracture is evaluated to be high, defined by the presence of one of the following inclusion criteria: * Individuals on a Heath Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk * Prior hip or clinically diagnosed vertebral fracture or prior multiple fragility fractures since age 40 * Fracture at any skeletal site (excluding skull, hands, and feet) within the previous 2 years * Ten-year probability of major osteoporotic fracture of ≥20% using the FRAX tool * BMD T-score of ≤ -2.0 (performed as part of usual clinical care) WITH either the presence of one or more moderate or severe vertebral fractures on spine radiography OR the presence of ≥1 comorbidities (Diabetes Type I or Type II if on treatment, Parkinson's disease, congestive heart failure, chronic obstructive pulmonary disease (COPD) with previous systemic corticosteroid exposure, prostate cancer with current or prior recent (≤ 2 years) use of hormonal therapy) OR ≥ 2 falls in the previous year * BMD T-score of ≤ -2.5 and ≥ 70 years of age Exclusion Criteria: * Inability to communicate in English or French; * No access to a mobile device, tablet, or computer with a camera; * Clinical or symptomatic spine fracture in the last 4 months, or a lower/upper limb fracture in the last 2 months; * Uncontrolled medical comorbidity including but not limited to congestive heart failure exacerbation in the last 12 months or COPD exacerbation in the last 3 months * Currently doing or planning to start doing either: A) Resistance training exercises with a self-rated intensity of very hard (e.g., rated ≥ 8 on a scale from 0-10) for two or more times a week OR B) Exercises to improve balance for two or more times a week * Unable to perform basic activities of daily living or severe cognitive impairment or terminal illness * Presence of absolute exercise contraindications unless physician approval is obtained if contraindications are present

Locations (5)

University of Calgary

Calgary, Alberta, Canada

McMaster University

Hamilton, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Québec

Québec, Quebec, Canada