Clinical trial NCT06774508: Feasibility of High-intensity Functional Exercise with Simultaneous Cognitive Challenge for Older People with Falls Risk
Official title: The Feasibility of a High-intensity Functional Exercise Program with Simultaneous Cognitive Challenge to Improve Physical and Cognitive Function in Older People with Intermediate Risk for Falls: a Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Accidental Falls
Postural Balance
Gait
Cognition
Keywords: Accidental falls
Postural balance
Gait
Cognition
Exercise therapy
Resistance training
Aged
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Västerbotten
First posted: 2025-01-14
Enrollment: 33
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims:

1. To investigate the acceptability and safety of the HIFE+cog program in older people at risk of falls, and the methods used in the study by evaluating recruitment, compliance with the intervention, severity of adverse events reported, and participant experiences.
2. To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences.

The study is designed as a randomized controlled pilot trial. Eligible participants will be randomized to either the intervention group (HIFE+cog) or the active control group (HIFE) to partake in individually tailored exercise, supervised and progressed by a physiotherapist, two times per week for 3 months.


Eligibility criteria: Inclusion Criteria:

* aged 75 years or older
* moderate risk of falling (feeling unsteady or afraid of falling, or having fallen in the past year, with a self-selected gait speed ≤0,8 m/s or TUG \>15 s without walking aid)
* can walk independently indoors, without a walking aid
* can walk 500m independently outdoors, with or without a walking aid

Exclusion Criteria:

* a high fall risk (≥2 falls in the past year, serious injury e.g. hip fracture from a fall in the past year requiring medical care, or inability to get up from the floor after a fall)
* Mini-Mental State Examination (MMSE) score \<24 or dementia diagnosis
* a medical condition that may affect participation in high-intensity gait, balance, and leg strength exercise, or other movement-related conditions affecting exercise or tests (e.g., pain, dizziness, visual or hearing impairment)

Primary outcomes:
measure: Recruitment
timeFrame: Before intervention start
measure: Adherence
timeFrame: Through the 3-month intervention
measure: Exercise intervention content and delivery
timeFrame: Through the 3-month intervention
measure: Retention
timeFrame: Through the 3-month intervention
measure: Safety
timeFrame: Through the 3-month intervention period
measure: Balance and gait capacity
timeFrame: Baseline, 3 months
measure: Balance and gait capacity
timeFrame: Baseline, 3 months
measure: Balance and gait capacity
timeFrame: Baseline, 3 months
measure: Balance and gait capacity
timeFrame: Baseline, 3 months
measure: Balance and gait capacity
timeFrame: Baseline, 3 months
measure: Cognitive function
timeFrame: Baseline, 3 months
measure: Cognitive function
timeFrame: Baseline, 3 months
measure: Cognitive function
timeFrame: Baseline, 3 months
measure: Cognitive function
timeFrame: Baseline, 3 months
measure: Cognitive function
timeFrame: Baseline, 3 months
measure: Cognitive function
timeFrame: Baseline, 3 months
measure: Occupational performance
timeFrame: Baseline, 3 months
measure: Experiences of the intervention and effects
timeFrame: 3 months
Secondary outcomes:
measure: Fear of falling
timeFrame: Baseline, 3 months
measure: Psychological wellbeing
timeFrame: Baseline, 3 months
measure: Physical activity
timeFrame: Baseline, 3 months
measure: Depressive disorders
timeFrame: Baseline, 3 months
measure: Health related quality of life
timeFrame: Baseline, 3 months
measure: Activities of daily life (ADL)
timeFrame: Baseline, 3 months
measure: Descriptive information
timeFrame: Baseline
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University
name: Annika Toots, PhD
role: PRINCIPAL_INVESTIGATOR
References: