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

Phase 3

Recruiting

• Conditions: Older Adults; Hospitalization
• Interventions: Other: Intervention 1 (simple exercise program); Other: Intervention 2 (comprehensive exercise program)

• Registration Number: NCT05366075
• Lead Sponsor: Karolinska Institutet

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 Timeline

• Study First Submitted: 2022-05-01
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Study Start: 2022-09-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention 1 (simple exercise program)	Intervention 1 (simple exercise program)	The intervention will include up to four sessions per day. It consists of sit-to stand exercises and walking along the corridor of the ward (for those who can walk).
Intervention 2 (comprehensive exercise program)	Intervention 2 (comprehensive exercise program)	This intervention consists of two daily sessions (morning and afternoon). The morning session includes individualized supervised progressive resistance, balance, and walking training exercises, tailored to each participant's capacity. The resistance training includes using weight cuffs, involving mainly lower-extremity muscles. Balance and gait exercises includes different exercises such as line walking, stepping practice, and walking with small obstacles. The evening session consists of functional exercises using light loads, such as knee extension and flexion, hand training with a ball, and daily walking exercises (for those who can walk).

Primary Outcome Measures

Name	Time	Method
Physical function	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 Outcome Measures

Name	Time	Method
Sarcopenia	Change from baseline (hospital admission) to 3 months after discharge	Defined by grip strength and calf- and arm circumferences according to the European Working Group's revised criteria on Sarcopenia in Older People
Activities of daily living	Change from baseline (hospital admission) to 3 months after discharge	Barthel Index (Possible score: 0-100, a higher score represents a better functional ability)
Health related quality of life	Change from baseline (hospital admission) to 3 months after discharge	EuroQol-5 Dimension
Mortality data	Up to 1 year after hospital discharge	Data on vital status will be collected using administrative data
Number of falls	From hospital discharge to 3 months after discharge	According to self-report
Number of readmissions	Up to 1 year after hospital discharge	Data on readmissions will be collected using administrative data

Trial Locations

Locations (1)

Anna-Karin Welmer; 🇸🇪 Huddinge, Sweden