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

NCT ID: NCT05366075

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Hospitalization Older Adults

Keywords

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Exercise Hospitalization Older Adults Physical Functional Performance Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Intervention 1 (simple exercise program)

Intervention Type 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 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).

Group Type EXPERIMENTAL

Intervention 2 (comprehensive exercise program)

Intervention Type 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).

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 Type OTHER

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Council for Working Life and Social Research

OTHER

Sponsor Role collaborator

Center for Innovative Medicine

UNKNOWN

Sponsor Role collaborator

Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Anna-Karin Welmer

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anna-Karin Welmer

Huddinge, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Anna-Karin Welmer, PhD

Role: CONTACT

Phone: +46852488804

Email: [email protected]

Facility Contacts

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Anna-Karin Welmer, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38905174 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37607787 (View on PubMed)

Other Identifiers

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2021-01788

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FoUI-961330

Identifier Type: -

Identifier Source: org_study_id