COVID-19 InfectionCov-activityNCT04647682
Physical Activity Program Implementation in Hospitalized Positive COVID-19 Older Adults
An observational study of COVID-19 Infection, run by University Hospital, Toulouse at 3 sites in 2 countries.
Trial summary
Our hypothesis was that physical activity program will be acceptable and may counteract physical and mental decline among older adults hospitalized in COVID-19 unit Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- physical activity program
- How many people
- 62 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 5 Jan 2021to 14 Feb 2022
- Phase
- Observational
- 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
Study population: Included in a French COVID-19 geriatric unit in Toulouse, hospitalized for a positive COVID-19 infection
Who may be able to join
- Patients aged 75 years and over
- Hospitalized in a French COVID-19 geriatric unit
- Positive COVID-19 infection made by Real-time Polymerase Chain Reaction COVID-19 or suspected on thoracic lesions on computerized tomography.
Who cannot join
- Severe dementia or Mini Mental State Examination (MMSE) [14] below 18/30
- Acute COVID-19 complication.
- Activities of Daily Living < 2/6
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
CHU de Grenoble
Grenoble
University Hospital Toulouse
Toulouse, 31059
About this study
Official title: Feasibility and Effect of Implementing Physical Activity Program Implementation During COVID-19 in Hospitalized Positive COVID-19 Older Adults
Our hypothesis was that physical activity program will be acceptable and may counteract physical and mental decline among older adults hospitalized in COVID-19 unit
Read the detailed description
The 30 second chair test, balance with joint-feet and semi-tandem stance, and 4 meters comfortable walking test were evaluated. Depending on their score, a specific physical activity (PA) program was selected and explained. The program was printed, explained and left in the room. This intervention included 5 different PA programs.
Final evaluation (one day before leaving the unit) recording physical performance (same physical tests used for inclusion evaluation), Hospital Anxiety and depression (HAD) score, Activities Daily Living (ADL) and self-satisfaction of the program.
- Conditions
- COVID-19 Infection
- Being tested
- physical activity program
- Keywords
- older adults, hospital, physical activity program
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity programOther
- 30 second chair test,
- balance with joint-feet and semi-tandem stance
- 4 meters comfortable walking test were evaluated
| Study group | Role | What they receive |
|---|---|---|
| One single group study | Patients aged 75 years and over Hospitalized in a French COVID-19 geriatric unit Positive COVID-19 infection made by Real-time Polymerase Chain Reaction COVID-19 or suspected on thoracic lesions on computerized tomography. Receives: Other: physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of adherence of the intervention
adherence of the intervention evaluated by the number of completed exercise days compared to the number of total intervention days
Measured: through study completion, an average of 15 days
Secondary outcomes (1)
Change of physical performances
Comparison between inclusion and final physical performances measured by the 30-second chair test, balance with joint-feet, semi-tandem stance, 4 meters comfortable walking test, functional abilities with the evaluation of ADL score and HAD scores.
Measured: through study completion, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start5 Jan 2021
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves ROLLAND, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647682
- Sponsor's protocol ID
- RC31/20/0145
- Acronym
- Cov-activity
- Status last verified
- May 2023
- First submitted
- 29 Oct 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Andre L, Rolland Y, Gerard S, Kergoat MJ, Peyrusque E, Aubertin-Leheudre M. Feasibility and Effect of Implementing Physical Activity Program Implementation during Covid-19 in Hospitalized Positive Covid-19 Older Adults. J Nutr Health Aging. 2021;25(6):724-726. doi: 10.1007/s12603-021-1596-4. No abstract available.
PubMed 34179924
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effect of Implementing Physical Activity Program Implementation During COVID-19 in Hospitalized Positive COVID-19 Older Adults
- ClinicalTrials.gov ID
- NCT04647682
- Acronym / sponsor ID
- Cov-activity / RC31/20/0145
- Conditions
- COVID-19 Infection
- Keywords
- older adults, hospital, physical activity program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 1 Dec 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.
Our hypothesis was that physical activity program will be acceptable and may counteract physical and mental decline among older adults hospitalized in COVID-19 unit
Detailed description
The 30 second chair test, balance with joint-feet and semi-tandem stance, and 4 meters comfortable walking test were evaluated. Depending on their score, a specific physical activity (PA) program was selected and explained. The program was printed, explained and left in the room. This intervention included 5 different PA programs.
Final evaluation (one day before leaving the unit) recording physical performance (same physical tests used for inclusion evaluation), Hospital Anxiety and depression (HAD) score, Activities Daily Living (ADL) and self-satisfaction of the program.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One single group study | – | Other: physical activity programPatients aged 75 years and over Hospitalized in a French COVID-19 geriatric unit Positive COVID-19 infection made by Real-time Polymerase Chain Reaction COVID-19 or suspected on thoracic lesions on computerized tomography. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Included in a French COVID-19 geriatric unit in Toulouse, hospitalized for a positive COVID-19 infection
Key inclusion criteria (3 listed)
- Patients aged 75 years and over
- Hospitalized in a French COVID-19 geriatric unit
- Positive COVID-19 infection made by Real-time Polymerase Chain Reaction COVID-19 or suspected on thoracic lesions on computerized tomography.
Key exclusion criteria (3 listed)
- Severe dementia or Mini Mental State Examination (MMSE) [14] below 18/30
- Acute COVID-19 complication.
- Activities of Daily Living < 2/6
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 |
|---|---|---|
| physical activity program* 30 second chair test, * balance with joint-feet and semi-tandem stance * 4 meters comfortable walking test were evaluated | Other | One single group study |
Primary outcome
Change of adherence of the intervention
Time frame: through study completion, an average of 15 days
adherence of the intervention evaluated by the number of completed exercise days compared to the number of total intervention days
1 secondary outcome
Change of physical performances
Time frame: through study completion, an average of 15 days
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 1 Jun 2023.
- Background: PubMed 34179924Andre L, Rolland Y, Gerard S, Kergoat MJ, Peyrusque E, Aubertin-Leheudre M. Feasibility and Effect of Implementing Physical Activity Program Implementation during Covid-19 in Hospitalized Positive Covid-19 Older Adults. J Nutr Health Aging. 2021;25(6):724-726. doi: 10.1007/s12603-021-1596-4. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Yves ROLLAND, MD principal investigator
University Hospital, Toulouse
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection, run by University Hospital, Toulouse at 3 sites in 2 countries.
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 3 inclusion and 3 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 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Guadeloupe. 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?
Change of adherence of the intervention (time frame: through study completion, an average of 15 days). 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 NCT04647682, which also lists 1 linked publication.
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 1 Jun 2023.