Actively Recruiting
Feasibility of a High-intensity Functional Exercise Program with Simultaneous Cognitive Challenge to Improve Physical and Cognitive Function in Older People at Risk of Falls
Led by Umeå University · Updated on 2025-02-25
33
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
R
Region Västerbotten
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of a high-intensity functional exercise program combined with simultaneous cognitive challenges (HIFE+cog) for older adults at risk of falls. This randomized controlled pilot trial aims to assess the acceptability, safety, recruitment, adherence, and participant experiences of this combined exercise and cognitive program compared to a high-intensity functional exercise program alone (HIFE). The study focuses on people aged 75 years and older with moderate fall risk to improve their physical and cognitive functions. Participants will be randomly assigned to one of two groups: the HIFE+cog group or the HIFE group. Both groups will perform individually tailored exercises focused on lower leg strengthening, static and dynamic balance, and weight-bearing positions. The HIFE+cog group will also complete cognitive exercises simultaneously with balance exercises. Each session lasts about one hour, including warm-up, and is held twice weekly in supervised groups for 12 weeks. During the study, researchers will monitor recruitment, adherence, safety, and retention throughout the 3-month intervention. Assessments will be conducted at baseline and after 3 months to measure balance, gait capacity, cognitive function, occupational performance, fear of falling, psychological wellbeing, physical activity, depressive symptoms, health-related quality of life, and daily living activities. Participant experiences of the intervention and its effects will also be collected. The study aims to provide estimates and data to plan future trials.
CONDITIONS
Brief Title
Feasibility of High-intensity Functional Exercise with Simultaneous Cognitive Challenge for Older People with Falls Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 75 years or older
- Moderate risk of falling (feeling unsteady, afraid of falling, or fallen in the past year with gait speed ≤0.8 m/s or Timed Up and Go test >15 seconds without walking aid)
- Can walk independently indoors without a walking aid
- Can walk 500 meters independently outdoors with or without a walking aid
You will not qualify if you...
- High fall risk (2 or more falls in the past year, serious injury such as hip fracture from a fall requiring medical care, or inability to get up from the floor after a fall)
- Mini-Mental State Examination (MMSE) score less than 24 or diagnosis of dementia
- Medical conditions affecting participation in high-intensity gait, balance, and leg strength exercises, including pain, dizziness, or visual/hearing impairments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take part in a high-intensity functional exercise program, either with or without a simultaneous cognitive challenge, performed twice weekly in supervised groups.
Twice weekly visits for 12 weeks
Duration - Up to 3 months from baseline
Participants are assessed for balance, gait capacity, cognitive function, occupational performance, and other outcomes after completing the exercise program.
1 follow-up visit at 3 months
Trial Site Locations
Total: 1 location
1
Umeå University
Umeå, Sweden, 90187
Actively Recruiting
Research Team
A
Annika Toots, PhD
M
Magdalena Eriksson Domellöf, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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