Falls, Frailty, Mild Cognitive Impairment
Conditions
Keywords
execise, falls, cognitive frailty
Brief summary
The Problem: The proposed trial will address the problem of how to effectively prevent subsequent falls in community-dwelling cognitively frail older adults with a history of falls. Primary Question: In community-dwelling older adults with cognitive frailty and a history of falls, can a home-based exercise program with behavioural change techniques significantly reduce falls vs. health education (i.e., control; CON)?
Detailed description
Rationale: Falls are a significant cause of functional decline and often a sentinel event. Older adults with cognitive frailty - those with concurrent physical frailty and mild cognitive impairment - are at particular risk for falls. Notably, falls can cause a sudden and severe change in their health state from one of independence to one of dependence. Thus, effective falls prevention strategies need to be identified for older adults with cognitive frailty. The Otago Exercise Program (OEP) - a physical therapist (PT) delivered home-based exercise program - is an evidence-based falls prevention program for community-dwelling older adults. Our pilot data show the OEP vs. usually care significantly reduced subsequent falls in 192 community-dwelling older adults with cognitive frailty and a history of falls; the incident rate ratio was 0.64 (95% CI, 0.43-0.98; P = .042). These preliminary findings need to be confirmed in a rigorously designed RCT powered for falls in older adults with cognitive frailty; none exist to date. We also observed lower OEP adherence among older adults with cognitive frailty vs. those without cognitive frailty. Thus, strategies to support adherence must be considered in RCTs of exercise to prevent falls in this high-risk population. Evidence-based strategies include health coaching. Thus, we propose a 12-month multi-site randomized controlled trial (RCT) in older adults with cognitive frailty and a history of falls to assess the efficacy of the OEP combined with health coaching (i.e., OEP+) to prevent falls. Primary Question: In community-dwelling older adults with cognitive frailty and a history of falls, can the OEP+ significantly reduce falls vs. health education (i.e., control; CON)? Secondary Questions: 1) What are additional benefits of the OEP+ vs. CON? 2) Do the benefits of OEP+ persist 6 months post cessation? 3) Can the OEP+ reduce falls or improve quality of life at similar or lower costs vs. CON? Methods: A 12-month assessor-blinded, multi-site RCT, with a 6-month follow-up, in older adults, with cognitive frailty - defined by a Short Physical Performance Battery score \<= 9/12 and a Montreal Cognitive Assessment score between 18-25/30 - and a history of falls. Participants will be randomized to either: a) OEP+ or b) CON. The OEP+ intervention will include Brief Action Planning-based health coaching. The CON group will include monthly interactive education sessions via Zoom. Measurement will occur at baseline, 6, 12, and 18 months, with falls tracked daily.
Interventions
BEHAVIORALBalance and Strength Training Exercises with Health Coaching
The OEP+ intervention integrates the OEP with health coaching by a physical therapists or kinesiologist. The OEP is an individualized home-based balance and strength exercise training program delivered by a PT or kinesiologist coach over 5 home visits.
OTHEREducation Session
All active comparator participants will be invited to join monthly interactive social and education sessions via Zoom or in-person (hybrid delivery).
Sponsors
University of British Columbia
Vancouver Coastal Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
We will include individuals who meet the following criteria: 1) aged between 65 and 89 years; 2) live in Greater Vancouver, British Columbia; 3) are community-dwelling (i.e., not residing in a nursing home or extended care unit); 4) experienced a non-syncopal fall in the prior 12 months; 5) scored ≤ 9/12 on the SPPB; 6) have subjective cognitive impairment based on interview; 7) scored 18-25/30 on the MoCA \[62,64\]; 8) are able to walk with or without a gait aid; 9) scored ≥ 6/8 on Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) \[65\]; 10) are able to safely engage in exercise as indicated by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) \[66\]; and 11) are able to understand, speak, and read English with sufficient proficiency to complete the assessments. \*The age maximum of 89 was set due to the increased risk of significant adverse health outcomes cognitively frail older adults face. As this population has an increased risk of falls, functional disability with loss of independence, hospitalization, and death, setting an age maximum aims to increase the likelihood that participants will be able to complete the 18-month study without interruptions due to health complications. This age limit has been reviewed and approved by CIHR.
Exclusion criteria
We will exclude individuals who: 1) have been diagnosed with dementia, a neurodegenerative disease, or stroke; 2) report engaging in strength and balance training exercises ≥ 2 times per week in the prior 3 months; 3) have severe depression based on a score of ≥ 11/15 on the GDS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Falls | Daily tracking over 12 months | The number of self-reported falls during the 12-month intervention period (i.e., rate of falls). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery | Baseline, 6 months, 12 months, 18 months | A physical performance battery out of 12 points (max. performance). |
| Montreal Cognitive Assessment | Baseline, 6 months, 12 months, 18 months | A test that covers multiple cognitive domains. Often used to screen for mild cognitive impairment. |
| Falls during followup period | Daily tracking from 12 months (trial completion) to end of 6-month followup (18 months) | The number of self-reported falls during the 6-month ifollowup period (i.e., rate of falls). |
| NIH Cognitive Toolbox | Baseline, 6 months, 12 months, 18 months | Cognitive function measured using the NIH Cognitive Toolbox: Dimensional Change Card Sort Test and Flanker Inhibitory Control and Attention Test |
| Processing speed | Baseline, 6 months, 12 months, 18 months | Processing speed measured by Digit Symbol Substitution Test |
| Memory | Baseline, 6 months, 12 months, 18 months | Memory measured by the Rey Auditory Verbal Learning Test |
| Gait Speed | Baseline, 6 months, 12 months, 18 months | Walking speed in m/s measured over 4 meters (part of the Short Physical Performance Battery) |
| Muscle Strength | Baseline, 6 months, 12 months, 18 months | Dominant quadriceps strength and dominant hand grip strength. |
| Community Mobility | Baseline, 6 months, 12 months, 18 months | Life Space Questionnaire to measure community mobility |
| Functional Mobility | Baseline, 6 months, 12 months, 18 months | Timed Up and Go Test to measure functional mobility |
| Fatigue | Baseline, 6 months, 12 months, 18 months | The 9-item Fatigue Severity Scale will be used to assess how fatigue interferes with certain activities and its severity. |
| Quality of Life | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months | The EuroQol EQ-5 Domain (5D)-5 Level (5L) (EQ-5D-5L) and the EuroQol Visual Analogue Scale (EQ-VAS) will assess quality of life |
| Fear of Falling | Baseline, 6 months, 12 months, 18 months | Fear of falling as assessed by the Iconographical Falls Efficacy Scale (Icon-FES). |
| Health Resource Utilization (HRU) | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months | Cost data will be collected every 3 months using the HRU questionnaire |
| Sleep Quality (Objective) - Optional | Baseline, 6 months, 12 months, 18 months | Sleep quality parameters will be measured using ActiGraph |
| Brain Function - Optional | Baseline, 6 months, 12 months | Brain function will be measured using functional near-infrared spectroscopy |
| Physical Frailty | Baseline, 6 months, 12 months, 18 months | The Short Physical Performance Battery (physical performance battery out of 12 points (max. performance) and the Fried Frailty Phenotype (scores range from 0-5 where 0 is characterized as non-frail, 1-2 as pre-frail and \>=3 as frail) |
| Physical Activity | Baseline, 6 months, 12 months, 18 months | The Physical Activity Scale for the Elderly (PASE) will be used to measure physical activity levels. PASE is a 12-item scale. |
| Mood | Baseline, 6 months, 12 months, 18 months | 15-item Geriatric Depression Scale (GDS) will be used to assess depressive symptoms. GDS score of \>=11/15 is suggestive of severe depression |
| Fall Risk | Baseline, 6 months, 12 months, 18 months | Fall risk is assessed by the Physiological Profile Assessment (PPA). A PPA z-score of 0-1 is indicative of mild fall risk, 1-2 indicates moderate risk, 2-3 indicates high risk, and \> 3 indicates marked risk |
| Frailty Index | Baseline, 6 months, 12 months, 18 months | A frailty index will be calculated based on an accumulation of deficits across multiple domains and constructed using our primary and secondary outcome measures. |
Countries
Canada
Contacts
CONTACTTeresa Liu-Ambrose, PhD
PRINCIPAL_INVESTIGATORTeresa Liu-Ambrose, PhD
University of British Columbia
Outcome results
None listed