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

Study Overview
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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.

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

Conditions
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Hospitalization, Older Adults

Intervention / Treatment
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* Other: Intervention 1 (simple exercise program)
* Other: Intervention 2 (comprehensive exercise program)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention 2 (comprehensive exercise program)<br>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)<br>* 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).<br>|
| No Intervention: Control group<br>The control group will receive usual care, which may include physical rehabilitation when needed. | |
| Experimental: Intervention 1 (simple exercise program)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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) | 
| Health related quality of life | EuroQol-5 Dimension | Change from baseline (hospital admission) to 3 months after discharge | 
| 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) | 
| 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 | 
| 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) | 
| Number of falls | According to self-report | From hospital discharge to 3 months after discharge | 
| Mortality data | Data on vital status will be collected using administrative data | Up to 1 year after hospital discharge | 
| Number of readmissions | Data on readmissions will be collected using administrative data | Up to 1 year after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Hospitalization, Older Adults, Physical Functional Performance, Randomized Controlled Trial