HospitalizationPREV_FUNCNCT05366075
The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study
A study testing Intervention 1 (simple exercise program) and Intervention 2 (comprehensive exercise program) in people with Hospitalization and Older Adults, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hospitalization, Older Adults
- What is being tested?
- Intervention 1 (simple exercise program) and Intervention 2 (comprehensive exercise program)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2022to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ability to stand up from a sitting position independently or with minimal personal help
- ability to communicate and collaborate with the research staff
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this 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.
Read the detailed 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.
- Conditions
- Hospitalization, Older Adults
- Being tested
- Intervention 1 (simple exercise program), Intervention 2 (comprehensive exercise program)
- Keywords
- Exercise, Hospitalization, Older Adults, Physical Functional Performance, Randomized Controlled Trial
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Intervention 2 (comprehensive exercise program) |
| Control group | No intervention | The control group will receive usual care, which may include physical rehabilitation when needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Short Physical Performance Battery (Possible score: 0-12), a higher score represents a better physical function)
Measured: 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)
Measured: Change from baseline (hospital admission) to 3 months after discharge
Secondary outcomes (10)
Activities of daily living
Barthel Index (Possible score: 0-100, a higher score represents a better functional ability)
Measured: 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)
Measured: Change from baseline (hospital admission) to 3 months after discharge
Health related quality of life
EuroQol-5 Dimension
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline (hospital admission) to 3 months after discharge
Number of falls
According to the logbooks at the hospital
Measured: 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
Measured: From hospital discharge to 3 months after discharge
Mortality data
Data on vital status will be collected using administrative data
Measured: Up to 1 year after hospital discharge
Number of readmissions
Data on readmissions will be collected using administrative data
Measured: Up to 1 year after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Sep 2022
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research, Center for Innovative Medicine, Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse
- Responsible party
- Principal investigator, Anna-Karin Welmer, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366075
- Sponsor's protocol ID
- FoUI-961330
- Other IDs
- 2021-01788
- Acronym
- PREV_FUNC
- Status last verified
- Aug 2026
- First submitted
- 1 May 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38905174Welmer 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.
PubMed 37607787
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventing Functional Decline in Acutely Hospitalized Older Patients (PREV_FUNC) Study
- ClinicalTrials.gov ID
- NCT05366075
- Acronym / sponsor ID
- PREV_FUNC / FoUI-961330
- Conditions
- Hospitalization, Older Adults
- Keywords
- Exercise, Hospitalization, Older Adults, Physical Functional Performance, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research, Center for Innovative Medicine, Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 (simple exercise program) | Experimental | Other: 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). |
| Intervention 2 (comprehensive exercise program) | Experimental | Other: 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). |
| Control group | No intervention | –The control group will receive usual care, which may include physical rehabilitation when needed. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- ability to stand up from a sitting position independently or with minimal personal help
- ability to communicate and collaborate with the research staff
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention 1 (simple exercise program) |
| 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). | Other | Intervention 2 (comprehensive exercise program) |
Primary outcome
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)
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)
10 secondary outcomes
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)
Activities of daily living
Time frame: Change from baseline (hospital admission) to 3 months after discharge
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)
Health related quality of life
Time frame: Change from baseline (hospital admission) to 3 months after discharge
Sarcopenia
Time frame: Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
Sarcopenia
Time frame: Change from baseline (hospital admission) to 3 months after discharge
Number of falls
Time frame: Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)
Number of falls
Time frame: From hospital discharge to 3 months after discharge
Mortality data
Time frame: Up to 1 year after hospital discharge
Number of readmissions
Time frame: Up to 1 year after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 38905174Sandberg 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.
- Derived from this study: PubMed 37607787Welmer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 (simple exercise program) and Intervention 2 (comprehensive exercise program) in people with Hospitalization and Older Adults, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function (time frame: Change from baseline (hospital admission) to completion of the hospital-based exercises (at discharge around 1 week after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05366075, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.