The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Physical function
Overview
Brief Summary
This study aims to examine 1) if multicomponent exercise interventions (including both mobility and strengthening exercises) have effects on physical function compared to usual care in older adults, and 2) if a comprehensive multicomponent exercise program is more effective than a simple multicomponent exercise program including only walking and rising from a chair.
Detailed Description
This is a three-armed randomized controlled trial, with two intervention groups (comprehensive and simple exercise program) and a control group receiving usual care. Participants aged ≥75 years will be included consecutively from geriatric medical wards of hospitals in Stockholm, Sweden. Assessments will be conducted at hospital admission, discharge and three months thereafter concerning physical function (primary outcome), activities of daily living, health-related quality of life, sarcopenia, and falls. Number of re-admissions and mortality will be registered up to 1 year after discharge.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 75 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ability to stand up from a sitting position independently or with minimal personal help
- •ability to communicate and collaborate with the research staff
Exclusion Criteria
- •people who are not able to follow instructions
- •people who by the responsible physician are assessed as not eligible to participate due to terminal illness or any major medical condition that contraindicates exercise
- •those living in nursing home
- •those previously included in the study
Outcomes
Primary Outcomes
Physical function
Time Frame: Change from baseline (hospital admission) to 3 months after discharge
Short Physical Performance Battery (Possible score: 0-12), a higher score represents a better physical function)
Secondary Outcomes
- Sarcopenia(Change from baseline (hospital admission) to 3 months after discharge)
- Activities of daily living(Change from baseline (hospital admission) to 3 months after discharge)
- Health related quality of life(Change from baseline (hospital admission) to 3 months after discharge)
- Mortality data(Up to 1 year after hospital discharge)
- Number of falls(From hospital discharge to 3 months after discharge)
- Number of readmissions(Up to 1 year after hospital discharge)
Investigators
Anna-Karin Welmer
Associate professor
Karolinska Institutet