Physical ActivityACTI-PACTNCT04327115
Study of an Physical Exercise Program on Older People of 75 Years Old and More, Hospitalized in Geriatric Short Stay
A study testing "Intervention" strategy in people with Physical Activity and Aged, run by University Hospital, Angers at 1 site in France.
Trial summary
The main objective is to assess the effect, compared to usual care, of a nursing accompaniment or nursing assistant intervention in the physical activity of patients hospitalized in the geriatric stay, on the daily number of steps. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Physical Activity, Aged
- What is being tested?
- "Intervention" strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2021to 20 Dec 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
- Men or women ≥ 75 years old
- Hospitalization in geriatric short stay
- Informed and express (oral) consent to participate in the study by the patient or the patient's representative
- Affiliation to French Social Security.
Who cannot join
- Neurological or orthopedic pathology that prevents the performance of one or more exercises corresponding to the patient's level of risk of falling
- Short expected hospital stay
- Contraindication to physical activity
- Person subject to a safeguard of justice measure
- Patient who previously participated to the study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cédric ANNWEILER , MD, PhD
Angers, 49933
Cedric ANNWEILER, MD, (+33)241354725, ceannweiler@chu-angers.fr
About this study
Official title: ACTI-PACT : Programme d'ACcompagnement à l'acTIvité Physique Chez la Personne Âgée de 75 Ans et Plus, hospitalisée en CourT séjour gériatrique
The main objective is to assess the effect, compared to usual care, of a nursing accompaniment or nursing assistant intervention in the physical activity of patients hospitalized in the geriatric stay, on the daily number of steps.
The secondary objectives consist in evaluating the effect, compared to usual care, of a nursing or nursing assistant's intervention in physical activity of elderly patients hospitalized on a short geriatric stay in terms of:
- The change of the daily physical exertion in metabolic equivalent
- The change of the daily number of steps
- The change of care course
- The change of in falls occurrence
- The change of autonomy patient
- The change of travels habits
Read the detailed description
The aging of the French population leads to a significant increase in elderly hospitalizations. These patients are often dependent, polymorbid and precarious from a medical, social and economic point of view, bringing them into a frailty process to which the health system is trying to adapt. In fact, the absence of specific care adapted to frail elderly patients results in an increased risk of functional maladjustment. It is characterized by a loss, during hospitalization, of the ability to perform the activities of daily living alone and a decrease in physical activity. This maladjustment can differ or even prevent return home, increases the risk of falling, the length of stay and health expenses.
The concept of frailty in the elderly is mainly based on the concept of physical vulnerability, and in particular muscular vulnerability. Increasing attention is therefore being paid to physical activity in the elderly, which can prevent the process of maladjustment.
The 2004802 Decree of July 29, 2004 recalls that nurses lift patients and help them to walk without using rehabilitation techniques, to ensure their comfort. The interest of such an approach has already been reported, especially in primary care where nursing support allows a sustained and lasting increase in physical activity in the elderly. To the best of the investigators' knowledge, the effectiveness of such a nursing approach to physical activity support has not been studied in hospitals yet.
The investigators looked for exercises simple, fast and adapted to an elderly population with a very diverse functional maladjustment. The selected intervention is a physical activity based on the activities of daily living to improve postural balance and strengthening the muscles of the lower limbs. This intervention follows the main principles of the latest recommendations of the French High Authority for Health on the elderly fall prevention. It resumes acts such as sitting or standing on a foot corresponding to static equilibrium conditions. It also proposes carrying out transfers from a sitting to standing position and from a standing to sitting position corresponding to motor acts for the lower limbs.
The investigators hypothesize that formalized paramedical support in a geriatric short-stay service prevents the elderly from decreasing their physical activity, and prevents the occurrence of falls and early re-hospitalization.
- Conditions
- Physical Activity, Aged
- Being tested
- "Control" strategy, "Intervention" strategy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Control" strategyProcedure or surgery
Patients included in the "control" group will received the usual cares of the unit during their stay : support in the gestures of daily life and walking according to their ability and at the discretion of the care teams.
"Intervention" strategyProcedure or surgery
Patients included in the "intervention" group will received the usual cares of the unit during their stay : support in the gestures of daily life and walking according to their ability and at the discretion of the care teams.
They will also get a physical activity program realized with a nurse or a nursing assistant, twice a day (morning and evening) for 5 days. The intervention consists of physical support with mimed instructions, the nature of which depends on the falling risk of the participant :
- High falling risk : "out of bed" exercise (on a chair for at least 30 min)
- Mild falling risk : "out of bed" exercise + "in front of chair" (The participant stands standing in static equilibrium to a chair holding the back of it for 2 minutes, on both feet or one foot)
- Low falling risk : "out of bed" exercise + "in front of chair" + FTSS exercise (The participant performs a transfer activity of sitting to standing repeated 5 times, with physical assistance or not)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | (C-I-I-I) : the centers apply the "Control" strategy in Period 1 and then apply the "Intervention" strategy in Periods 2 to 4. Receives: Procedure: "Control" strategy; Procedure: "Intervention" strategy |
| Arm 2 | Other | (C-C-I-I) : the centers apply the "Control" strategy in periods 1 and 2 and then apply the "Intervention" strategy in periods 3 and 4. Receives: Procedure: "Control" strategy; Procedure: "Intervention" strategy |
| Arm 3 | Other | (C-C-C-I) : the centers apply the "Control" strategy in periods 1, 2 and 3 and then apply the "Intervention" strategy for period 4. Receives: Procedure: "Control" strategy; Procedure: "Intervention" strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of steps
the relative evolution of the number of steps between the 1st day (D1) and the 5th day (D5) is calculated with this formula : Δ nbsteps (%) = (D5 number of steps - D1 number of steps)*100 / ((D1 number of steps + D5 number of steps)/2).
Measured: this outcome is assessed at Day 5 after inclusion.
Secondary outcomes (8)
Change in the daily physical expenditure in metabolic equivalent
The daily physical expenditure is evaluated by the actimeter in MET (Metabolic Equivalent of Task)
Measured: This outcome is assessed between Day 1 and Day 5.
Change in the daily number of steps
The daily number of steps is evaluated by the actimeter
Measured: This outcome is assessed between Day 1 and Day 5.
Change in the daily physical expenditure
The daily physical expenditure is evaluated by the actimeter
Measured: This outcome is assessed between Day 1 and Day 5.
Change in care course
The care course is evaluated by the length of hospitalization
Measured: This outcome is assessed between Day 0 and Day 60.
Change in care course
The care course is assessed by the occurrence of a new hospitalization
Measured: This outcome is assessed between Day 6 and Day 30.
Change in falls occurrence
The falls occurrence is assessed by the number of falls reported by the participant
Measured: This outcomes is assessed between Day 0 and Day 6, then while the 60 days after inclusion.
Change in patient autonomy
Autonomy is assessed with Activities of Daily Living (ADL) score. ADL is an autonomy assessment grid (from 0 to 6) for basic activities of daily living (ADL). The lower the score, the more dependent the patient is.
Measured: This outcomes is assessed at baseline and 60 days after inclusion.
Change in moving habits
Moving habits are assessed with the Life-Space Assessment questionnaire. 120 is the highest score (the best mobility) 0 is the worst score (the worst mobility)
Measured: This outcomes is assessed at baseline and 60 days after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start21 Oct 2021
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- stepped wedge cluster randomised trial
- Masking
- None (open label)
- Enrolment
- 864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327115
- Sponsor's protocol ID
- 2019-A01800-57
- Acronym
- ACTI-PACT
- Status last verified
- Jun 2024
- First submitted
- 23 Mar 2020
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTI-PACT : Programme d'ACcompagnement à l'acTIvité Physique Chez la Personne Âgée de 75 Ans et Plus, hospitalisée en CourT séjour gériatrique
- ClinicalTrials.gov ID
- NCT04327115
- Acronym / sponsor ID
- ACTI-PACT / 2019-A01800-57
- Conditions
- Physical Activity, Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 864 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 30 Mar 2020 (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.
The main objective is to assess the effect, compared to usual care, of a nursing accompaniment or nursing assistant intervention in the physical activity of patients hospitalized in the geriatric stay, on the daily number of steps.
The secondary objectives consist in evaluating the effect, compared to usual care, of a nursing or nursing assistant's intervention in physical activity of elderly patients hospitalized on a short geriatric stay in terms of:
- The change of the daily physical exertion in metabolic equivalent
- The change of the daily number of steps
- The change of care course
- The change of in falls occurrence
- The change of autonomy patient
- The change of travels habits
Detailed description
The aging of the French population leads to a significant increase in elderly hospitalizations. These patients are often dependent, polymorbid and precarious from a medical, social and economic point of view, bringing them into a frailty process to which the health system is trying to adapt. In fact, the absence of specific care adapted to frail elderly patients results in an increased risk of functional maladjustment. It is characterized by a loss, during hospitalization, of the ability to perform the activities of daily living alone and a decrease in physical activity. This maladjustment can differ or even prevent return home, increases the risk of falling, the length of stay and health expenses.
The concept of frailty in the elderly is mainly based on the concept of physical vulnerability, and in particular muscular vulnerability. Increasing attention is therefore being paid to physical activity in the elderly, which can prevent the process of maladjustment.
The 2004802 Decree of July 29, 2004 recalls that nurses lift patients and help them to walk without using rehabilitation techniques, to ensure their comfort. The interest of such an approach has already been reported, especially in primary care where nursing support allows a sustained and lasting increase in physical activity in the elderly. To the best of the investigators' knowledge, the effectiveness of such a nursing approach to physical activity support has not been studied in hospitals yet.
The investigators looked for exercises simple, fast and adapted to an elderly population with a very diverse functional maladjustment. The selected intervention is a physical activity based on the activities of daily living to improve postural balance and strengthening the muscles of the lower limbs. This intervention follows the main principles of the latest recommendations of the French High Authority for Health on the elderly fall prevention. It resumes acts such as sitting or standing on a foot corresponding to static equilibrium conditions. It also proposes carrying out transfers from a sitting to standing position and from a standing to sitting position corresponding to motor acts for the lower limbs.
The investigators hypothesize that formalized paramedical support in a geriatric short-stay service prevents the elderly from decreasing their physical activity, and prevents the occurrence of falls and early re-hospitalization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- stepped wedge cluster randomised trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: "Control" strategy, Procedure: "Intervention" strategy(C-I-I-I) : the centers apply the "Control" strategy in Period 1 and then apply the "Intervention" strategy in Periods 2 to 4. |
| Arm 2 | Other | Procedure: "Control" strategy, Procedure: "Intervention" strategy(C-C-I-I) : the centers apply the "Control" strategy in periods 1 and 2 and then apply the "Intervention" strategy in periods 3 and 4. |
| Arm 3 | Other | Procedure: "Control" strategy, Procedure: "Intervention" strategy(C-C-C-I) : the centers apply the "Control" strategy in periods 1, 2 and 3 and then apply the "Intervention" strategy for period 4. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Men or women ≥ 75 years old
- Hospitalization in geriatric short stay
- Informed and express (oral) consent to participate in the study by the patient or the patient's representative
- Affiliation to French Social Security.
Key exclusion criteria (5 listed)
- Neurological or orthopedic pathology that prevents the performance of one or more exercises corresponding to the patient's level of risk of falling
- Short expected hospital stay
- Contraindication to physical activity
- Person subject to a safeguard of justice measure
- Patient who previously participated to 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 |
|---|---|---|
| "Control" strategyPatients included in the "control" group will received the usual cares of the unit during their stay : support in the gestures of daily life and walking according to their ability and at the discretion of the care teams. | Procedure or surgery | Arm 1, Arm 2, Arm 3 |
| "Intervention" strategyPatients included in the "intervention" group will received the usual cares of the unit during their stay : support in the gestures of daily life and walking according to their ability and at the discretion of the care teams. They will also get a physical activity program realized with a nurse or a nursing assistant, twice a day (morning and evening) for 5 days. The intervention consists of physical support with mimed instructions, the nature of which depends on the falling risk of the participant : * High falling risk : "out of bed" exercise (on a chair for at least 30 min) * Mild falling risk : "out of bed" exercise + "in front of chair" (The participant stands standing in static equilibrium to a chair holding the back of it for 2 minutes, on both feet or one foot) * Low falling risk : "out of bed" exercise + "in front of chair" + FTSS exercise (The participant performs a transfer activity of sitting to standing repeated 5 times, with physical assistance or not) | Procedure or surgery | Arm 1, Arm 2, Arm 3 |
Primary outcome
Change in the number of steps
Time frame: this outcome is assessed at Day 5 after inclusion.
the relative evolution of the number of steps between the 1st day (D1) and the 5th day (D5) is calculated with this formula : Δ nbsteps (%) = (D5 number of steps - D1 number of steps)*100 / ((D1 number of steps + D5 number of steps)/2).
8 secondary outcomes
Change in the daily physical expenditure in metabolic equivalent
Time frame: This outcome is assessed between Day 1 and Day 5.
Change in the daily number of steps
Time frame: This outcome is assessed between Day 1 and Day 5.
Change in the daily physical expenditure
Time frame: This outcome is assessed between Day 1 and Day 5.
Change in care course
Time frame: This outcome is assessed between Day 0 and Day 60.
Change in care course
Time frame: This outcome is assessed between Day 6 and Day 30.
Change in falls occurrence
Time frame: This outcomes is assessed between Day 0 and Day 6, then while the 60 days after inclusion.
Change in patient autonomy
Time frame: This outcomes is assessed at baseline and 60 days after inclusion.
Change in moving habits
Time frame: This outcomes is assessed at baseline and 60 days after inclusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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.
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" strategy in people with Physical Activity and Aged, run by University Hospital, Angers at 1 site in France.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cédric ANNWEILER, MD, PhD (+33 2 41 35 54 86 ext. +33, cedric.annweiler@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of steps (time frame: this outcome is assessed at Day 5 after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2024.