Chronic DiseaseCAPACITY70NCT04644861
Adapted Physical Activity Centre (in The) CITY for Elders Aged 70 and Over with At Least One Long Term Illness
A study testing Program of adapted physical activity in people with Chronic Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Elders aged 70 and over, living in Toulouse, with a chronic disease identified by the French social insurance as an Affection Longue Durée will be eligible to a 4 months physical activity program in a primary health center. This program will be proposed by their general practitioner. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Program of adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2020to 21 Feb 2023
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elders aged 70 and over, with a chronic disease recognize as an Long Term Affection by the French social insurance.
- Living at home in Toulouse
- With a general practitioner working in Toulouse and agreed to participate to the CAPA-CITY70 program research
Who cannot join
- Elders living in nursing home
- Elders dependent for daily activity (score < 5.5 Autonomy scale of Katz)
- Elders with dementia according to DSM V criteria
- Elders participating in another research project
- Contraindication for physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Feasibility of a Physical Activity Program Adapted for Primary Care, for People Aged 70 and Over Who Have At Least One Long-term Illness
Elders aged 70 and over, living in Toulouse, with a chronic disease identified by the French social insurance as an Affection Longue Durée will be eligible to a 4 months physical activity program in a primary health center. This program will be proposed by their general practitioner. The aim of the study is to establish the feasibility of such program conduced exclusively in primary care.
Read the detailed description
The number of elders aged 70 and over and suffering of a chronic disease are increasing in our country. These patients are at risk of sarcopenia which can lead to an increasing risk of falls and hospitalization, loss of autonomy, and morbi-mortality. Twelve weeks adapted physical activity program can manage sarcopenia in elders. One of the difficulties to propose such a program to elders patients is the difficulty to reach the program center due to mobility deficiency. Our hypothesis is that proposing an adapted physical activity in a primary health care center, in the city of the patient, could help the participation.
Eligible patients addressed by their general practitioner will perform 4 months adapted physical activity program in the CAPA-CITY center (MSPU La Providence).
The inclusion will be realized by the sports doctor of CAPA-CITY. At M2, sport doctor and adapted physical activity teacher will meet the patient to readapt the program taking in count his particularity and wishes.
At M4 M6 and M12, an independent global evaluation will be realized by training nurse and clinical research associate.
- Conditions
- Chronic Disease
- Being tested
- Program of adapted physical activity
- Keywords
- Chronic Disease, adapted physical activity, primary care, Motor Activity, Elders
- Medical subject headings
- Chronic Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program of adapted physical activityOther
3 workouts of one hour every week during 4 months. Program will be conducted by adapted physical activity teachers and sports doctor.
| Study group | Role | What they receive |
|---|---|---|
| Elders aged 70 | Other | Program of adapted physical activity Receives: Other: Program of adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of the adapted physical activity program (ratio 1)
total number of patients included in the study
Measured: Month 0
feasibility of the adapted physical activity program (ratio 2)
number of patients who complete the program of adapted physical activity in totality
Measured: Month 4
Secondary outcomes (10)
feasibility complementary criteria Month 0
number of patients who start the program of adapted physical activity
Measured: Month 0
feasibility complementary criteria Month 4
reasons to not complete the program of adapted physical activity
Measured: Month 4
organization feasibility
number of canceled sessions
Measured: Month 4
program adhesion (sessions realised)
numbers of realised session
Measured: Month 4
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome
Measured: Month 0
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome
Measured: Month 4
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome
Measured: Month 12
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Global Physical Activity Questionnaire (GPAQ). Score from 0 to 3000. higher score mean better outcome
Measured: Month 0
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Global Physical Activity Questionnaire (GPAQ), Score from 0 to 3000, higher score mean better outcome
Measured: Month 6
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Global Physical Activity Questionnaire (GPAQ), Score from 0 to 3000, higher score mean better outcome
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start14 Dec 2020
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emile ESCOURROU, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644861
- Sponsor's protocol ID
- RC31/19/0057
- Other IDs
- 2020-A01164-35
- Acronym
- CAPACITY70
- Status last verified
- Sep 2024
- First submitted
- 3 Nov 2020
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of a Physical Activity Program Adapted for Primary Care, for People Aged 70 and Over Who Have At Least One Long-term Illness
- ClinicalTrials.gov ID
- NCT04644861
- Acronym / sponsor ID
- CAPACITY70 / RC31/19/0057
- Conditions
- Chronic Disease
- Keywords
- Chronic Disease, adapted physical activity, primary care, Motor Activity, Elders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 25 Nov 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.
Elders aged 70 and over, living in Toulouse, with a chronic disease identified by the French social insurance as an Affection Longue Durée will be eligible to a 4 months physical activity program in a primary health center. This program will be proposed by their general practitioner. The aim of the study is to establish the feasibility of such program conduced exclusively in primary care.
Detailed description
The number of elders aged 70 and over and suffering of a chronic disease are increasing in our country. These patients are at risk of sarcopenia which can lead to an increasing risk of falls and hospitalization, loss of autonomy, and morbi-mortality. Twelve weeks adapted physical activity program can manage sarcopenia in elders. One of the difficulties to propose such a program to elders patients is the difficulty to reach the program center due to mobility deficiency. Our hypothesis is that proposing an adapted physical activity in a primary health care center, in the city of the patient, could help the participation.
Eligible patients addressed by their general practitioner will perform 4 months adapted physical activity program in the CAPA-CITY center (MSPU La Providence).
The inclusion will be realized by the sports doctor of CAPA-CITY. At M2, sport doctor and adapted physical activity teacher will meet the patient to readapt the program taking in count his particularity and wishes.
At M4 M6 and M12, an independent global evaluation will be realized by training nurse and clinical research associate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elders aged 70 | Other | Other: Program of adapted physical activityProgram of adapted physical activity |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elders aged 70 and over, with a chronic disease recognize as an Long Term Affection by the French social insurance.
- Living at home in Toulouse
- With a general practitioner working in Toulouse and agreed to participate to the CAPA-CITY70 program research
Key exclusion criteria (5 listed)
- Elders living in nursing home
- Elders dependent for daily activity (score < 5.5 Autonomy scale of Katz)
- Elders with dementia according to DSM V criteria
- Elders participating in another research project
- Contraindication for physical activity
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 |
|---|---|---|
| Program of adapted physical activity3 workouts of one hour every week during 4 months. Program will be conducted by adapted physical activity teachers and sports doctor. | Other | Elders aged 70 |
Primary outcome
feasibility of the adapted physical activity program (ratio 1)
Time frame: Month 0
total number of patients included in the study
feasibility of the adapted physical activity program (ratio 2)
Time frame: Month 4
number of patients who complete the program of adapted physical activity in totality
10 secondary outcomes
feasibility complementary criteria Month 0
Time frame: Month 0
feasibility complementary criteria Month 4
Time frame: Month 4
organization feasibility
Time frame: Month 4
program adhesion (sessions realised)
Time frame: Month 4
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
Time frame: Month 0
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
Time frame: Month 4
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
Time frame: Month 12
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Time frame: Month 0
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Time frame: Month 6
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Time frame: Month 12
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 25 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Disease
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
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.
Emile ESCOURROU principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program of adapted physical activity in people with Chronic Disease, run by University Hospital, Toulouse 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 3 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: finished, as of the sponsor's last update on 25 Sep 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?
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?
feasibility of the adapted physical activity program (ratio 1) (time frame: Month 0). 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?
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 25 Sep 2024.