The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study

Older Adults Clinical Trial

— PREV_FUNC  

Official title:

The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366075
• Other study ID #: FoUI-961330
• Secondary ID: 2021-01788
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Karolinska Institutet
• Contact: Anna-Karin Welmer, PhD
• Phone: +46852488804
• Email: anna-karin.welmer[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hospitalization
• Older Adults

Intervention

Other:
• Intervention 1 (simple exercise program)
Up 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)
Two 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).

Locations

Country	Name	City	State
Sweden	Anna-Karin Welmer	Huddinge

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Center for Innovative Medicine, Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse, Swedish Council for Working Life and Social Research

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function	Short Physical Performance Battery (Possible score: 0-12), a higher score represents a better physical function)	Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
Primary	Physical function	Short Physical Performance Battery (Possible score: 0-12), a higher score represents a better physical function)	Change from baseline (hospital admission) to 3 months after discharge
Secondary	Activities of daily living	Barthel Index (Possible score: 0-100, a higher score represents a better functional ability)	Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
Secondary	Activities of daily living	Barthel Index (Possible score: 0-100, a higher score represents a better functional ability)	Change from baseline (hospital admission) to 3 months after discharge
Secondary	Health related quality of life	EuroQol-5 Dimension	Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
Secondary	Health related quality of life	EuroQol-5 Dimension	Change from baseline (hospital admission) to 3 months after discharge
Secondary	Sarcopenia	Defined by grip strength and calf- and arm circumferences according to the European Working Group's revised criteria on Sarcopenia in Older People	Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
Secondary	Sarcopenia	Defined by grip strength and calf- and arm circumferences according to the European Working Group's revised criteria on Sarcopenia in Older People	Change from baseline (hospital admission) to 3 months after discharge
Secondary	Number of falls	According to the logbooks at the hospital	Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
Secondary	Number of falls	According to self-report	From hospital discharge to 3 months after discharge
Secondary	Mortality data	Data on vital status will be collected using administrative data	Up to 1 year after hospital discharge
Secondary	Number of readmissions	Data on readmissions will be collected using administrative data	Up to 1 year after hospital discharge