Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults (Otago)

Fall Clinical Trial

Official title:

Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04851405
• Other study ID #: H19-01760
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: Stephanie Therrien, BA
• Phone: 604-207-4053
• Email: stherrien[@]arthritisresearch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Falls are a major health care problem for seniors. The Otago Exercise Program, which consists of strength and balance training delivered by a physiotherapist, can reduce falls in this population. We will test two methods to deliver the Otago program. These will include a new coaching approach by a physiotherapist with the use of a Fitbit to provide feedback versus the traditional delivery. The degree to which the program is delivered as intended by physiotherapists as well as the number of falls, risk of falling, and participation in walking activities in older adults will be assessed over 24 months. Lastly, we will assess if the coaching approach is a cost-effective option.

Description:

Falls are a major health care problem for older adults (i.e., those aged ≥ 65 years) and health care systems. Falls account for 50% of injury-related admissions to hospital, 40% of admissions to nursing homes, and a 10% increase in home care services. They are also the leading cause of fatal injury among Canadians over 65 years old. This represents a significant health burden. Fortunately, falls are preventable. There is strong evidence that the Otago Exercise Program (OEP), physiotherapist (PT)-led home-based exercise program of strength and balance training, is effective at preventing falls in older adults with complex medical conditions. Originally developed in New Zealand the OEP has been implemented worldwide, but adherence to the program is a challenge. We propose that the suboptimal adherence is partly due to a lack of focus on behaviour change techniques such as self-monitoring and action planning in the delivery of OEP. The investigators will use a mixed-methods approach, involving a RCT and in-depth interviews. The delivery of OEP+ vs OEP, from PTs, and its recipients, the older adults, will be determined at random. The training for the PT's will be provided by the Centre for Collaboration Motivation & Innovation (CCMI), a non-profit organization with a mandate to support the use of behaviour change techniques to improve health care. Prior to data collection, the PTs will attend a 2-hour workshop on the coaching protocol using the OEP app. The goal of this project is to assess OEP+ as an implementation strategy to improve OEP delivery (by PTs) and adherence (by older adults).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria (Older Adults):

• over 70 years of age
• self-report a non-syncopal fall corroborated by an informant, in the previous six months
• are able to walk three meters with or without an assistive device
• have a Mini-Mental State Examination score > 24/30
• have a Physiological Profile Assessment composite score of at least 1.0 standard deviation above age-normative value or have a Timed Up and Go test > 15 seconds, or had one additional non-syncopal fall in the previous 12 months
• live in an area served by Vancouver Coastal Health
• understand, speak, and read English proficiently
• have access to a mobile device
• are willing to have their OEP sessions audio-recorded
• able to provide written informed consent

Exclusion Criteria (Older Adults):

• people not meeting the criteria above

Inclusion Criteria (Physiotherapists):

• willing to participate in training on the OEP
• complete the BAP training
• be audio-recorded during the OEP sessions
• be randomized to the OEP group with coaching or without coaching

Exclusion Criteria (Physiotherapists):

• not willing to participate in the above criteria

Related Conditions & MeSH terms

• Fall
• Frailty
• Old Age; Debility

Intervention

Behavioral:
• Otago Exercise Programme+ (OEP+)
Physiotherapists (PTs) will receive OEP and BAP training. They will provide at home visits and follow-up phone calls to the older adult participants (5 at home visits and 3 phone calls). Older adults will have access to the OEP app.
• Otago Exercise Programme (OEP)
PTs will receive OEP training. They will provide at home visits and follow-up phone calls to the older adult participants (5 at home visits and 3 follow-up phone calls).

Locations

Country	Name	City	State
Canada	Arthritis Research Canada	Vancouver	British Columbia

Sponsors (5)

Lead Sponsor	Collaborator
University of British Columbia	Arthritis Research Centre of Canada, Simon Fraser University, Vancouver Coastal Health Research Institute, Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiotherapist-level outcome - Brief Action Planning (BAP) Scores	This measure includes 33 items from three domains: 1) BAP content, 2) warmth and tone, and 3) overall interaction quality (total score: 0-35, higher score = better). The scores will be derived from the physiotherapists' sessions with the first, middle (Participant 3 or 4 out of 8) and last older adult participant. The recording from these treatment sessions will be coded and analysed by one of four researchers. The average of BAP scores of the middle and last participants for each PT will be used in the analysis .	During the 12-month intervention
Primary	Older Adult-Level Outcome - rate of adherence to the Otago Exercise Program (OEP)	The number of exercise completed out of the total number of exercise prescribed during the intervention period	During the 12-month intervention
Secondary	Older Adult-Level Outcome - Number of Falls	Number of falls reported by the older adult participants. We define falls as "an event which results in a person coming to rest inadvertently on the ground or floor or other lower level".	During the 12-month intervention
Secondary	Older Adult-Level Outcome - Number of Falls	Number of falls during the reported. We define falls as "an event which results in a person coming to rest inadvertently on the ground or floor or other lower level".	During the 12 months after the intervention (i.e., 13-24 months)
Secondary	Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)	PPA assesses risk of falls. Based on the performance of five domains (postural sway, hand reaction time, quadriceps strength, proprioception, and edge contrast sensitivity), a fall risk score will be computed for each participant. The PPA has a 75% predictive accuracy for falls in older people. A PPA z-score of 0-1 indicates mild risk, >1-2 indicates moderate risk, >2-3 indicates high risk, and >3 and above indicates marked risk.	Baseline
Secondary	Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)	PPA assesses risk of falls. Based on the performance of five domains (postural sway, hand reaction time, quadriceps strength, proprioception, and edge contrast sensitivity), a fall risk score will be computed for each participant. The PPA has a 75% predictive accuracy for falls in older people. A PPA z-score of 0-1 indicates mild risk, >1-2 indicates moderate risk, >2-3 indicates high risk, and >3 and above indicates marked risk.	6 months
Secondary	Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)	PPA assesses risk of falls. Based on the performance of five domains (postural sway, hand reaction time, quadriceps strength, proprioception, and edge contrast sensitivity), a fall risk score will be computed for each participant. The PPA has a 75% predictive accuracy for falls in older people. A PPA z-score of 0-1 indicates mild risk, >1-2 indicates moderate risk, >2-3 indicates high risk, and >3 and above indicates marked risk.	12 months
Secondary	Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)	PPA assesses risk of falls. Based on the performance of five domains (postural sway, hand reaction time, quadriceps strength, proprioception, and edge contrast sensitivity), a fall risk score will be computed for each participant. The PPA has a 75% predictive accuracy for falls in older people. A PPA z-score of 0-1 indicates mild risk, >1-2 indicates moderate risk, >2-3 indicates high risk, and >3 and above indicates marked risk.	18 months
Secondary	Older Adult-Level Outcome - Physiological Profile Assessment© (PPA)	PPA assesses risk of falls. Based on the performance of five domains (postural sway, hand reaction time, quadriceps strength, proprioception, and edge contrast sensitivity), a fall risk score will be computed for each participant. The PPA has a 75% predictive accuracy for falls in older people. A PPA z-score of 0-1 indicates mild risk, >1-2 indicates moderate risk, >2-3 indicates high risk, and >3 and above indicates marked risk.	24 months
Secondary	Older Adult-Level Outcome - Average Daily Step Count	Measured by averaging the daily step counts, recorded by a Fitbit worn at the ankle (the non-dominant side), over seven days.	Baseline
Secondary	Older Adult-Level Outcome - Average Daily Step Count	Measured by averaging the daily step counts, recorded by a Fitbit worn at the ankle (the non-dominant side), over seven days.	6 months
Secondary	Older Adult-Level Outcome - Average Daily Step Count	Measured by averaging the daily step counts, recorded by a Fitbit worn at the ankle (the non-dominant side), over seven days.	12 months
Secondary	Older Adult-Level Outcome - Average Daily Step Count	Measured by averaging the daily step counts, recorded by a Fitbit worn at the ankle (the non-dominant side), over seven days.	18 months
Secondary	Older Adult-Level Outcome - Average Daily Step Count	Measured by averaging the daily step counts, recorded by a Fitbit worn at the ankle (the non-dominant side), over seven days.	24 months
Secondary	Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)	EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels, with a '1' indicating no problem and a '5' indicating major problem. The 5 dimensions (i.e., the health state profile) will be converted into a weighted health state utility values between '0' and '1', where '1' represents "perfect health" and '0' represents a health state equivalent to death. Values less than '0' indicate a health state worse than death. These health state utility values will provide weightings for QALYs. We will employ Canadian conversion tariffs for transforming health state profiles into utility scores.	Baseline
Secondary	Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)	EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels, with a '1' indicating no problem and a '5' indicating major problem. The 5 dimensions (i.e., the health state profile) will be converted into a weighted health state utility values between '0' and '1', where '1' represents "perfect health" and '0' represents a health state equivalent to death. Values less than '0' indicate a health state worse than death. These health state utility values will provide weightings for QALYs. We will employ Canadian conversion tariffs for transforming health state profiles into utility scores.	6 months
Secondary	Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)	EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels, with a '1' indicating no problem and a '5' indicating major problem. The 5 dimensions (i.e., the health state profile) will be converted into a weighted health state utility values between '0' and '1', where '1' represents "perfect health" and '0' represents a health state equivalent to death. Values less than '0' indicate a health state worse than death. These health state utility values will provide weightings for QALYs. We will employ Canadian conversion tariffs for transforming health state profiles into utility scores.	12 months
Secondary	Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)	EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels, with a '1' indicating no problem and a '5' indicating major problem. The 5 dimensions (i.e., the health state profile) will be converted into a weighted health state utility values between '0' and '1', where '1' represents "perfect health" and '0' represents a health state equivalent to death. Values less than '0' indicate a health state worse than death. These health state utility values will provide weightings for QALYs. We will employ Canadian conversion tariffs for transforming health state profiles into utility scores.	18 months
Secondary	Older Adult-Level Outcome - EuroQol-5D-5 Level version (EQ-5D-5L)	EQ-5D-5L is a generic preference-based utility measure composed of 5 domains of health (mobility, self-care, usual activities, pain, and anxiety/depression). Each domain contains 5 levels, with a '1' indicating no problem and a '5' indicating major problem. The 5 dimensions (i.e., the health state profile) will be converted into a weighted health state utility values between '0' and '1', where '1' represents "perfect health" and '0' represents a health state equivalent to death. Values less than '0' indicate a health state worse than death. These health state utility values will provide weightings for QALYs. We will employ Canadian conversion tariffs for transforming health state profiles into utility scores.	24 months
Secondary	Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)	The HRU asks for specific details regarding health professional visits, admissions to hospital, laboratory tests, use of medications, purchase of adaptive aids, and the productivity loss incurred by the older adults and their caregivers due to the person's poor health	Baseline
Secondary	Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)	The HRU asks for specific details regarding health professional visits, admissions to hospital, laboratory tests, use of medications, purchase of adaptive aids, and the productivity loss incurred by the older adults and their caregivers due to the person's poor health	3 months
Secondary	Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)	The HRU asks for specific details regarding health professional visits, admissions to hospital, laboratory tests, use of medications, purchase of adaptive aids, and the productivity loss incurred by the older adults and their caregivers due to the person's poor health	6 months
Secondary	Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)	The HRU asks for specific details regarding health professional visits, admissions to hospital, laboratory tests, use of medications, purchase of adaptive aids, and the productivity loss incurred by the older adults and their caregivers due to the person's poor health	9 months
Secondary	Older Adult-Level Outcome - Health Resource Utilization Questionnaire (HRU)	The HRU asks for specific details regarding health professional visits, admissions to hospital, laboratory tests, use of medications, purchase of adaptive aids, and the productivity loss incurred by the older adults and their caregivers due to the person's poor health	12 months