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

NCT05366075 | Recruiting Phase 3

• 2 other identifiers: FoUI-9613302021-01788
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospitalization; Older Adults

Keywords

Exercise; Hospitalization; Older Adults; Physical Functional Performance; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (10)

• Activities of daily living

  Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)

• 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 completion of the hospital-based exercises (at discharge around 1 week after baseline)

• Health related quality of life

  Change from baseline (hospital admission) to 3 months after discharge

• Sarcopenia

  Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)

Study Arms (3)

Intervention 1 (simple exercise program)

EXPERIMENTAL

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).

Other: Intervention 1 (simple exercise program)

Intervention 2 (comprehensive exercise program)

EXPERIMENTAL

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).

Other: Intervention 2 (comprehensive exercise program)

Control group

NO INTERVENTION

The control group will receive usual care, which may include physical rehabilitation when needed.

Interventions

Intervention 1 (simple exercise program) OTHER

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 1 (simple exercise program)

Intervention 2 (comprehensive exercise program) OTHER

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).

Intervention 2 (comprehensive exercise program)

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ability to stand up from a sitting position independently or with minimal personal help
• ability to communicate and collaborate with the research staff

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Council for Working Life and Social Research: collaborator
• Center for Innovative Medicine: collaborator
• Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse: collaborator

Study Sites (1)

Anna-Karin Welmer

Huddinge, 141 83, Sweden

RECRUITING

Related Publications (2)

• Sandberg L, Bostrom AM, Hagstromer M, Lindgren C, Kivipelto M, Sandlund C, Welmer AK. Feasibility of the "Preventing functional decline in acutely hospitalized older patients (PREV_FUNC)" study-A three-armed randomized controlled pilot trial. PLoS One. 2024 Jun 21;19(6):e0304570. doi: 10.1371/journal.pone.0304570. eCollection 2024.

  PMID: 38905174 DERIVED

• Welmer AK, Sandberg L, Sandlund C, Bjorck C, Hagstromer M, Hamilton J, Helgstrand G, Lindgren C, Nordstrand L, Sandstedt P, Kivipelto M, Bostrom AM. Study protocol for the 'preventing functional decline in acutely hospitalised older patients (PREV_FUNC)' study: effects of two multicomponent exercise programmes on physical function - a three-armed randomised controlled trial. BMJ Open. 2023 Aug 22;13(8):e070885. doi: 10.1136/bmjopen-2022-070885.

  PMID: 37607787 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Anna-Karin Welmer, PhD

CONTACT

+46852488804; anna-karin.welmer@ki.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 9, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)