Osteoporosis
Conditions
Keywords
Gait, Wearable, Walking, Falls, Fracture Risk
Brief summary
The aim of the Walk BEST study is to provide evidence that it is feasible to implement the technology assisted gait- focused walking program Walk-BEST™ in older adults with osteoporosis, and that this program is acceptable to this population.
Detailed description
The Walk-BEST™ technology assisted gait optimization program has demonstrated effectiveness in improving gait pattern and walking capacity without adverse events in people living with Parkinson's and Multiple Sclerosis. What is not known and the topic of this pilot and feasibility study is whether older people with osteoporosis will engage successfully with this program, since they do not have a diagnosis of a disabling condition affecting gait and may be unaware that their cautious method of walking exposes them to higher risk of falls and fractures rather than protecting them. A randomized pilot and feasibility study (PAFS) will be conducted with groups randomized in a 1:1 ratio. Participants will be randomly assigned to either 1) immediate receipt of the Walk-BEST™ program; or 2) wait-list control and delayed receipt of Walk-BEST™ program 3 months post-randomization. Participants will receive a copy of a proprietary workbook with instructions on simple exercises targeting strength, flexibility, and balance to facilitate a better walking pattern, as well as both 3-5 remote sessions with an exercise professional to practice walking well and to learn how to use the Heel2ToeTM sensor, and two technology phone calls with a research team member, over the first 4 weeks of the intervention. This personal gait training period will be followed by independent home practice over 2 months, during which participants will be instructed to practice walking with the sensor for a minimum period of 6 min, twice a day and to complete three exercises from their workbook at least twice a week. There will be three on-site study visits at 3-month intervals: one for initial assessment, and two for reassessment.
Interventions
DEVICEDevice: Heel2Toe[TM] sensor
Heel2Toe is a new generation of wearables that provides real-time auditory feedback when the person takes a good step, one in which the step is initiated with a strong heel strike.
BEHAVIORALTechnology-assisted therapeutic walking program
Co-designed, evidence-based technology-assisted, therapeutic walking program developed by physiotherapy researchers, clinicians, and frail and non-frail seniors. It consists of training elements (derived through international consensus and endorsed by 600 older Canadians) for optimal gait pattern with the use of a biofeedback device, the Heel2Toe™ sensor, which is introduced to reinforce the gait optimizing training and encourage home practice.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
All participants eventually receive the intervention. The primary outcomes are feasibility outcomes. Gait quality is measured directly from the sensor and is not affected by observers.
Intervention model description
Waist-List Control
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* men and women 70 years and older * able to walk independently with or without a walking aid * experienced a prior fracture after the age of 40, OR two falls in the past 12 months, OR who have a bone mineral density test (done as part of routine clinical evaluation) with a T-score \< -2.5, OR on a Health Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk or on a bisphosphonate drug holiday (planned treatment interruption)
Exclusion criteria
* fracture sustained in the past 12 months * unable to walk unsupervised because of active medical or neurocognitive reasons * unable to provide informed consent, or cannot communicate in English or French
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study recruitment rates (feasibility objective) | 3 months | The study will be considered feasible if the investigator can recruit 28 participants |
| Study retention rates (feasibility objective) | 9 months | The study will be considered feasible if ≥ 75 % of the sample completes the final assessment |
| Adherence to intervention (feasibility objective) | 9 months | The intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of walking sessions at the 6-month follow-up. |
| Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective) | 9 months | The acceptability outcomes will be based on an exit debriefing questionnaire. Usability of the Heel2Toe sensor will be quantified with items from the Digital Health Devices Usability Indicators. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional walking capacity | Change from Baseline to 3 months, 6 months | Six Minute Walk Test (6MWT) |
| Grip strength | Change from Baseline to 3 months, 6 months | Hand Dynamometer |
| Balance | Change from Baseline to 3 months, 6 months | Mini-Best Test (0-28; higher is better) |
| Functional leg muscle strength | Change from Baseline to 3 months, 6 months | 30-second Chair stand test |
| Fear of falling | Change from Baseline to 3 months, 6 months | 6-Item Revised Fear of Falling Questionnaire (6-24, lower is better) |
| Physical activity | Change from Baseline to 3 months, 6 months | Physical Activity Scale for the elderly (0-400+; higher is better) |
| Lower limb function | Change from Baseline to 3 months, 6 months | Lower Extremity Functional Scale (0-80; higher is better) |
| Quality of Life | Change from Baseline to 3 months, 6 months | Older Persons Active Living Related Quality of Life (8-32, higher is better) |
| Falls | Change from Baseline to 3 months, 6 months | Number of falls reported in the falls calendar |
Countries
Canada
Contacts
CONTACTVelizara Garkova, MSc
PRINCIPAL_INVESTIGATORSuzanne Morin, MD
RI-MUHC
Outcome results
None listed