Telehealth for Falls and Fracture Prevention Implementation Trial (TeleFFIT)

Not Applicable

Recruiting

• Conditions: Osteoporosis; Osteopenia; Falls risk; Fracture risk; Musculoskeletal - Osteoporosis; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12621001215819
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-10
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 386

Inclusion Criteria

Participants must be aged 60 years and over and classified at increased risk for falls/fracture defined as: 1) the presence of osteoporosis (as diagnosed by a doctor) or confirmed by a DXA scan during screening at Deakin University (proximal femur scan T-score equal to or less than -2.5 SD); 2) currently (or previously) treated for osteoporosis by medication, or 3) a previous history of a minimal trauma fracture (defined as a fracture resulting from trauma equal to (or less than) a fall from standing height) since the age of 50 years or at least 1 fall in the past 12 months, or at increased falls risk (score 3 or more) based on our Falls/Fracture risk questionnaire in combination with the presence of low BMD (osteopenia or osteoporosis) at the proximal femur (T-score <-1.0) as determine by DXA. To be included in the study, participants must also have access to a smart device/computer (including wi-fi/internet) and capable of making and receiving telephone and/or video conferencing calls and messaging (text/SMS), be willing to be randomized to either the TeleFFIT intervention (and undertake exercise for 12 months) or the usual care group and understand all the study requirements.

Exclusion Criteria

Participants will be excluded from the study based on the following:
1) history of a hip fracture in the past year;
2) acute/terminal illness, medical disorder or recent surgery likely to limit training or regular use of a walking frame;
3) currently being treated for cancer (or if treatment ceased in the past 3 months);
4) any progressive neurological condition (eg Parkinson’s disease, dementia/Alzheimer’s disease) or palliative condition;
5) currently involved in a regular structured exercise training program (resistance training, weight bearing exercises) or falls prevention program more than once a week;
6) BMI <18 or >40;
7) non-English speaking;
8) current and ongoing use of glucocorticoids, if >7.5 mg/d and for >3 months; aromatase inhibitors or anti-androgen therapy;
9) no access to a smart device/phone;
10) recent (last 3 months) or considering gastric bypass surgery in the next 12 months;
11) impaired capacity or unable to provide informed consent (inability to understand – reiterate – the purpose of the study and its requirements);
12) For those who do not pass the Exercise and Sports Science Australia (ESSA) pre-exercise screening tool, their GP does not provide consent for them to participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Falls rate monitored via falls calendars completed by participants daily[ 12 months post start of intervention];Femoral neck areal bone mineral density (aBMD) measured by DXA[ Baseline and 12 months]