The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age75+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ability to stand up from a sitting position independently or with minimal personal help
ability to communicate and collaborate with the research staff
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention 1 (simple exercise program)
Other interventionUp to four sessions per day (total duration 20-30 minutes/day). Performed at the hospital on all weekdays from baseline until hospital discharge (around 1 week). At discharge, the participants will be encouraged to continue with the exercise program at home.
Intervention 2 (comprehensive exercise program)
Other interventionTwo daily sessions (morning and afternoon) of 20 minutes' duration each. Performed at the hospital on all weekdays from baseline until hospital discharge (around 1 week).
Treatment groups
320 Participants
are divided into 3 treatment groupsGroup A: Intervention 1 (simple exercise program)Experimental treatment 1 intervention
Group B: Intervention 2 (comprehensive exercise program)Experimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Physical function
Short Physical Performance Battery (Possible score: 0-12), a higher score represents a better physical function)
Time frame
Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)2
Physical function
Short Physical Performance Battery (Possible score: 0-12), a higher score represents a better physical function)
Time frame
Change from baseline (hospital admission) to 3 months after dischargeSecondary outcomes
1
Activities of daily living
Barthel Index (Possible score: 0-100, a higher score represents a better functional ability)
Time frame
Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)2
Activities of daily living
Barthel Index (Possible score: 0-100, a higher score represents a better functional ability)
Time frame
Change from baseline (hospital admission) to 3 months after discharge3
Health related quality of life
EuroQol-5 Dimension
Time frame
Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)4
Health related quality of life
EuroQol-5 Dimension
Time frame
Change from baseline (hospital admission) to 3 months after dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Swedish Council for Working Life and Social Research
Collaborator
Center for Innovative Medicine
Collaborator
Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse
Collaborator
Source ClinicalTrials.gov