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

NCT05927623 | Completed DMC

• 1 other identifier: MP-37-2022-8396
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Study recruitment rates (feasibility objective)

  The study will be considered feasible if the investigators can recruit 12 participants per site within one year

  12 months

• Study retention rates (feasibility objective)

  The study will be considered feasible if ≥ 75 % of the sample completes the 12-month assessment

  12 months

• Adherence to the exercise and nutrition interventions (feasibility objective)

  The exercise intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of exercise sessions at the 12-month follow-up. The nutrition intervention will be considered feasible if participants attend 66% of the visits.

  12 months

• Perceived usability and satisfaction of the telehealth platform application (feasibility objective)

  Measured using the the System Usability Scale (SUS) where scores range from 0 (very poor) to 100 (excellent). Usability will be deemed to be acceptable if the mean SUS score is above 68 (SUS ≥ 68 = average user experience).

  12 months

Secondary Outcomes (16)

• Change of health-related quality of life

  0, 6, and 12 months

• Change in social isolation

  0, 6, and 12 months

• Change in the action planning phase of behaviour

  6 and 12 months

• Change in self-efficacy, or confidence, for behaviors related to physical activity and calcium intake

  0, 6, and 12 months

• Change in fear of falling in community-dwelling older adults

  0, 6, and 12 months

Study Arms (2)

Misterfit online group

EXPERIMENTAL

The Misterfit online group will receive a 12-month virtually-delivered fracture prevention intervention that includes a personalized gender-tailored strength training and balance-based exercise program, nutritional counselling and fall and fracture prevention education.

Behavioral: Multifaceted Virtual Fracture Prevention Program

MisterFit offline group

OTHER

The Misterfit offline group will act as an attention control group receiving a fracture prevention intervention with the same components as the experimental group, but the components will not be virtual, personalized or gender-tailored.

Behavioral: Attention Control

Interventions

Multifaceted Virtual Fracture Prevention Program BEHAVIORAL

* 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.

Misterfit online group

Attention Control BEHAVIORAL

* 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

MisterFit offline group

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Community-dwelling individuals ≥ 60 years who self-identify as men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (5)

University of Calgary

Calgary, Alberta, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Centre Hospitalier Universitaire de Québec

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Osteoporosis; Osteoporotic Fractures; Muscular Atrophy; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Suzanne Morin, MD

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physical measures including balance, muscle strength, and gait speed will be recorded by an outcome assessor blind to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Assessor-blind parallel group multicenter pilot RCT of 12 months duration.

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 3, 2023
• Study Start: February 7, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)