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

Karolinska Institute

Status and phase: Enrolling; Phase 3

Conditions: Hospitalization; Older Adults

Treatments: Other: Intervention 2 (comprehensive exercise program); Other: Intervention 1 (simple exercise program)

Study type: Interventional

Funder types: Other

Identifiers

NCT05366075

FoUI-961330

2021-01788 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 3 patient groups

Intervention 1 (simple exercise program)

Experimental group

Description:

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).

Treatment:

Other: Intervention 1 (simple exercise program)

Intervention 2 (comprehensive exercise program)

Experimental group

Description:

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).

Treatment:

Other: Intervention 2 (comprehensive exercise program)

Control group

No Intervention group

Description:

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