Clinical trial NCT05366075: The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study
Official title: The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hospitalization
Older Adults
Keywords: Exercise
Hospitalization
Older Adults
Physical Functional Performance
Randomized Controlled Trial
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
name: Center for Innovative Medicine
name: Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse
First posted: 2022-05-09
Enrollment: 320
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical function
timeFrame: Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
measure: Physical function
timeFrame: Change from baseline (hospital admission) to 3 months after discharge
Secondary outcomes:
measure: Activities of daily living
timeFrame: Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
measure: Activities of daily living
timeFrame: Change from baseline (hospital admission) to 3 months after discharge
measure: Health related quality of life
timeFrame: Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
measure: Health related quality of life
timeFrame: Change from baseline (hospital admission) to 3 months after discharge
measure: Sarcopenia
timeFrame: Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
measure: Sarcopenia
timeFrame: Change from baseline (hospital admission) to 3 months after discharge
measure: Number of falls
timeFrame: Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
measure: Number of falls
timeFrame: From hospital discharge to 3 months after discharge
measure: Mortality data
timeFrame: Up to 1 year after hospital discharge
measure: Number of readmissions
timeFrame: Up to 1 year after hospital discharge
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Anna-Karin Welmer
Study officials:
References: