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NCT Number: NCT05366075

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

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.

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Key information

Conditions

Hospitalization Behavior Motor Activity Older Adults

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anna-Karin Welmer

Huddinge, 141 83, Sweden

Location status: Recruiting

Location contact

Anna-Karin Welmer, PhD

CONTACT

[email protected]

+46852488804

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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).

Primary outcomes

  1. Physical function

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

    Short Physical Performance Battery (Possible score: 0-12), a higher score represents a better physical function)

  2. Physical function

    Time frame: 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 outcomes

  1. Activities of daily living

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

    Barthel Index (Possible score: 0-100, a higher score represents a better functional ability)

  2. Activities of daily living

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

    Barthel Index (Possible score: 0-100, a higher score represents a better functional ability)

  3. Health related quality of life

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

    EuroQol-5 Dimension

  4. Health related quality of life

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

    EuroQol-5 Dimension

  5. Sarcopenia

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

    Defined by grip strength and calf- and arm circumferences according to the European Working Group's revised criteria on Sarcopenia in Older People

  6. Sarcopenia

    Time frame: 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

  7. Number of falls

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

    According to the logbooks at the hospital

  8. Number of falls

    Time frame: From hospital discharge to 3 months after discharge

    According to self-report

  9. Mortality data

    Time frame: Up to 1 year after hospital discharge

    Data on vital status will be collected using administrative data

  10. Number of readmissions

    Time frame: Up to 1 year after hospital discharge

    Data on readmissions will be collected using administrative data

Study contacts

Contact information is provided by the study sponsor or research team.

Anna-Karin Welmer, PhD

CONTACT

[email protected]

+46852488804

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

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

Registry information

Acronym: PREV_FUNC

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 9, 2022
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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