Chronic DiseaseNCT04954209
Comparative Study in Long-term Commitment to Physical Activity After Two Different Resumption Programs
An observational study of Chronic Disease, run by Comité Départemental Olympique et Sportif de Seine Saint Denis.
Trial summary
Although physical activity remains an essential pillar of chronicle diseases treatment, long-term adherence to physical activity (PA) continues to prove problematic. A 2019 meta-analysis as well as an overview on the treatment of chronic diseases through physical activity recommend the development of strategies for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Physical activities in hospital and Physical activity outside hospital
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a chronic disease who don't practice physical activity, which is part of the treatment
Who may be able to join
- Adults with a chronic disease
- Consenting
- medical aptitude to physical activity
- registrated in one of the two resumption programs
Who cannot join
- Doing less than a session of physical activity per week during the resumption program
Trial locations and contacts
No sites are listed yet.
Oriane Odin contact
About this study
Although physical activity remains an essential pillar of chronicle diseases treatment, long-term adherence to physical activity (PA) continues to prove problematic. A 2019 meta-analysis as well as an overview on the treatment of chronic diseases through physical activity recommend the development of strategies for long-term adherence. Several research paths should be considered in this context.
Through the observation and the comparison of two different programs, the aim of this study is to explore what determining factors will predispose patients to include physical activity in their lifestyle and make a long-term commitment to it/to exercising.
Read the detailed description
Research design This is a multi-center, longitudinal, minimal risk, category 2 observational comparative study with a convergent parallel mixed method design (Creswell 2015).
The work and intervention arrangements of the two gateway programs are not altered by the research protocol, so the follow-up is strictly observational. As such, it should not affect the usual framework of care and follow-up of patients followed for a long-term condition.
It is a comparative study because it is based on the observation of 2 structures whose methods of care by the PA differ for the same objective.
The patients were followed up during the 3 months of the resumption program and then for 9 months following this program, i.e. 12 consecutive months, which makes it a longitudinal study.
The design is said to be a parallel mixed method study because in the first phase, quantitative data (attendance, quality of life, motivation via questionnaires) and qualitative data (interviews on the reasons for continuing or abandoning PA practice) are collected and analyzed at the same time and analyzed separately. QUANT+QUAL In the second phase, these data are combined in order to integrate the results from the quantitative and qualitative methods, which should allow for a cross-interpretation of the results. Using the convergent parallel mixed method, the qualitative data will complement the quantitative data in order to analyze PA behavior in relation to the interviews on factors that modified PA practice.
Process Data will be collected at T0 inclusion (at enrollment in the resumption program), at 3 months (end of the resumption program), at 6 and 12 months after inclusion.
Inclusion in the study (T0) will be performed by the physical activity educators at the time of enrollment in the corresponding resumption program. The study will be presented to patients meeting the inclusion criteria. And the physical activity educator will inform the patient and collect orally the patient's non-opposition to participate, as well as the non-opposition to the use of the patient's data. If the patient agrees, the physical activity educator will proceed to collect the following data: socio-demographic data, IPAQ, SF-12. The patient will then be informed of a forthcoming physical or telephone appointment for a semi-structured interview with the principal investigator on the reasons for entering the program. The patient will be given a letter of information about the progress of the study with the contact information of the principal investigator.
At the end of enrolment (T0), a copy of the inclusion form, the identification form and the data collected will be sent by email to the principal investigator who will anonymise them.
During 3 months, until T1, the program investigator collects the attendance data of each patient.
At T1, i.e. T0 + 3 months, the corresponding resumption program investigator transmits the attendance data as well as the data from the IPAQ, SF-12 and IMI tests collected during the orientation interview at the end of the program. Patients are informed of a future physical or telephone interview about intra-program factors that have changed PA behavior. Patients are also informed again about the further course of the study (interviews at 6 months and 1 year). In case of absence or temporary impossibility to complete all the tests with the physical activity educator, they can be carried out during a telephone interview.
At T2, i.e. T0 + 6 months, the principal investigator will meet the participants physically or by telephone 6 months (+/- 3 weeks) after their entry into the program. During this interview, the IPAQ, SF-12, and IMI tests were administered, as well as a semi-structured interview on the factors that allowed participants to maintain their PA and their PA practice over the past 3 months.
At T3, i.e., T0 + 12 months, the principal investigator conducted a physical or telephone interview with the participants 12 months (+/- 3 weeks) after they entered the program. During this interview, the IPAQ, SF-12 and IMI tests were administered, as well as a semi-structured interview on the factors allowing the maintenance of PA and the PA practice of the last 6 months.
- Conditions
- Chronic Disease
- Being tested
- Physical activities in hospital, Physical activity outside hospital
- Keywords
- physical activity
- 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.
Physical activities in hospitalOther
3 month in a resumption program of physical activity in hospital
Physical activity outside hospitalOther
3 month in a resumption program of physical activity outside hospital with discovery sessions
| Study group | Role | What they receive |
|---|---|---|
| Hospital program of resumption | Program of resumption with physical activities in the hospital Receives: Other: Physical activities in hospital | |
| Non hospital program of resumption | Program of resumption outside hospital with discovery sessions Receives: Other: Physical activity outside hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Practice of physical activity
During a year we follow the physical activity rate with the IPAQ questionary and interviews. With interviews we also question the kind of physical activity.
Measured: 12 month
Secondary outcomes (3)
Self-reported perceptions of quality of life
The evaluation of the quality of life will be measured at 4 points of the study via the SF-12 questionnaire.
The SF-12 is a general health assessment questionnaire derived from the SF-36: it combines synthetic information with a score on the physical dimension and a score on the mental dimension. It includes 12 items, divided into the same 8 dimensions as the SF-36 (physical activity; life and relationships with others; physical pain; perceived health; vitality; limitations due to psychological state; limitations due to physical state; psychological health. These eight dimensions are used to measure two summary scores of the quality of life of individuals: the physical composite score (PCS) and the mental composite score (MCS) (Leplège Alain, 2001).
Each quality of life score will be compared with the different phases of physical activity in order to monitor its evolution and influence on adherence to physical activity and its continuation.
Measured: 12 month
Perceptions of enjoyment in practice of physical activity
The enjoyment of physical activity will be measured at three points in the study, T1, T2 and T3, using the Intrinsic Motivation Inventory (IMI) questionnaire (McAuley et al., 1989). This scale determines the pleasure taken in the practice of physical activity over a given period. Using 4 statements (e.g., "I liked the activities I did"), responses are rated on a scale of 1 to 5 from "strongly disagree" to "strongly agree. A high score is synonymous with great pleasure in practicing physical activity.
Each score will be compared to the different phases of physical activity in order to follow the evolution and the influence of pleasure in the practice for its adherence and continuation.
Measured: 12 month
The qualitative motivational criteria of physical activity practice
The qualitative motivational criteria collected through 4 semi-structured interviews:
- at T0: reasons for entering the program
- at T1: intra-program factors that modified PA behavior
- at T2: information on PA practice following the program: supervised (what type of structure), independent, activity(ies) practiced + factors allowing PA maintenance and PA practice in the last 3 months
- at T3: information on PA practice following the program: supervised (what type of facility), independent, activity(ies) practiced + factors allowing PA maintenance and PA practice in the last 6 months
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study startSep 2021 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comité Départemental Olympique et Sportif de Seine Saint Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Riquier, PhD std, Principal investigator, Comité Départemental Olympique et Sportif de Seine Saint Denis / Université de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954209
- Sponsor's protocol ID
- PERSISTE
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All individual informations will be anonymous
Publications
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Omorou AY, Langlois J, Lecomte E, Briancon S, Vuillemin A. Cumulative and bidirectional association of physical activity and sedentary behaviour with health-related quality of life in adolescents. Qual Life Res. 2016 May;25(5):1169-78. doi: 10.1007/s11136-015-1172-7. Epub 2015 Nov 6.
PubMed 26542533Vuillemin A, Boini S, Bertrais S, Tessier S, Oppert JM, Hercberg S, Guillemin F, Briancon S. Leisure time physical activity and health-related quality of life. Prev Med. 2005 Aug;41(2):562-9. doi: 10.1016/j.ypmed.2005.01.006.
PubMed 15917053Lewis BA, Williams DM, Frayeh A, Marcus BH. Self-efficacy versus perceived enjoyment as predictors of physical activity behaviour. Psychol Health. 2016;31(4):456-69. doi: 10.1080/08870446.2015.1111372. Epub 2015 Nov 18.
PubMed 26541890Crain AL, Martinson BC, Sherwood NE, O'Connor PJ. The long and winding road to physical activity maintenance. Am J Health Behav. 2010 Nov-Dec;34(6):764-75. doi: 10.5993/ajhb.34.6.11.
PubMed 20604700Williams NH, Hendry M, France B, Lewis R, Wilkinson C. Effectiveness of exercise-referral schemes to promote physical activity in adults: systematic review. Br J Gen Pract. 2007 Dec;57(545):979-86. doi: 10.3399/096016407782604866.
PubMed 18252074Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
PubMed 9817135McAuley E, Duncan T, Tammen VV. Psychometric properties of the Intrinsic Motivation Inventory in a competitive sport setting: a confirmatory factor analysis. Res Q Exerc Sport. 1989 Mar;60(1):48-58. doi: 10.1080/02701367.1989.10607413.
PubMed 2489825Riquier O, Vuillemin A, Van Hoye A. PERSISTE: a mixed methods protocol to identify barriers and levers to a sustainable physical activity practice among patients with chronic disease after physical activity resumption programs. BMJ Open Sport Exerc Med. 2022 Jan 7;8(1):e001261. doi: 10.1136/bmjsem-2021-001261. eCollection 2022.
PubMed 35070353
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study in Long-term Commitment to Physical Activity After Two Different Resumption Programs
- ClinicalTrials.gov ID
- NCT04954209
- Acronym / sponsor ID
- PERSISTE
- Conditions
- Chronic Disease
- Keywords
- physical activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Comité Départemental Olympique et Sportif de Seine Saint DenisUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 8 Jul 2021 (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.
Although physical activity remains an essential pillar of chronicle diseases treatment, long-term adherence to physical activity (PA) continues to prove problematic. A 2019 meta-analysis as well as an overview on the treatment of chronic diseases through physical activity recommend the development of strategies for long-term adherence. Several research paths should be considered in this context.
Through the observation and the comparison of two different programs, the aim of this study is to explore what determining factors will predispose patients to include physical activity in their lifestyle and make a long-term commitment to it/to exercising.
Detailed description
Research design This is a multi-center, longitudinal, minimal risk, category 2 observational comparative study with a convergent parallel mixed method design (Creswell 2015).
The work and intervention arrangements of the two gateway programs are not altered by the research protocol, so the follow-up is strictly observational. As such, it should not affect the usual framework of care and follow-up of patients followed for a long-term condition.
It is a comparative study because it is based on the observation of 2 structures whose methods of care by the PA differ for the same objective.
The patients were followed up during the 3 months of the resumption program and then for 9 months following this program, i.e. 12 consecutive months, which makes it a longitudinal study.
The design is said to be a parallel mixed method study because in the first phase, quantitative data (attendance, quality of life, motivation via questionnaires) and qualitative data (interviews on the reasons for continuing or abandoning PA practice) are collected and analyzed at the same time and analyzed separately. QUANT+QUAL In the second phase, these data are combined in order to integrate the results from the quantitative and qualitative methods, which should allow for a cross-interpretation of the results. Using the convergent parallel mixed method, the qualitative data will complement the quantitative data in order to analyze PA behavior in relation to the interviews on factors that modified PA practice.
Process Data will be collected at T0 inclusion (at enrollment in the resumption program), at 3 months (end of the resumption program), at 6 and 12 months after inclusion.
Inclusion in the study (T0) will be performed by the physical activity educators at the time of enrollment in the corresponding resumption program. The study will be presented to patients meeting the inclusion criteria. And the physical activity educator will inform the patient and collect orally the patient's non-opposition to participate, as well as the non-opposition to the use of the patient's data. If the patient agrees, the physical activity educator will proceed to collect the following data: socio-demographic data, IPAQ, SF-12. The patient will then be informed of a forthcoming physical or telephone appointment for a semi-structured interview with the principal investigator on the reasons for entering the program. The patient will be given a letter of information about the progress of the study with the contact information of the principal investigator.
At the end of enrolment (T0), a copy of the inclusion form, the identification form and the data collected will be sent by email to the principal investigator who will anonymise them.
During 3 months, until T1, the program investigator collects the attendance data of each patient.
At T1, i.e. T0 + 3 months, the corresponding resumption program investigator transmits the attendance data as well as the data from the IPAQ, SF-12 and IMI tests collected during the orientation interview at the end of the program. Patients are informed of a future physical or telephone interview about intra-program factors that have changed PA behavior. Patients are also informed again about the further course of the study (interviews at 6 months and 1 year). In case of absence or temporary impossibility to complete all the tests with the physical activity educator, they can be carried out during a telephone interview.
At T2, i.e. T0 + 6 months, the principal investigator will meet the participants physically or by telephone 6 months (+/- 3 weeks) after their entry into the program. During this interview, the IPAQ, SF-12, and IMI tests were administered, as well as a semi-structured interview on the factors that allowed participants to maintain their PA and their PA practice over the past 3 months.
At T3, i.e., T0 + 12 months, the principal investigator conducted a physical or telephone interview with the participants 12 months (+/- 3 weeks) after they entered the program. During this interview, the IPAQ, SF-12 and IMI tests were administered, as well as a semi-structured interview on the factors allowing the maintenance of PA and the PA practice of the last 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital program of resumption | – | Other: Physical activities in hospitalProgram of resumption with physical activities in the hospital |
| Non hospital program of resumption | – | Other: Physical activity outside hospitalProgram of resumption outside hospital with discovery sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a chronic disease who don't practice physical activity, which is part of the treatment
Key inclusion criteria (4 listed)
- Adults with a chronic disease
- Consenting
- medical aptitude to physical activity
- registrated in one of the two resumption programs
Key exclusion criteria (1 listed)
- Doing less than a session of physical activity per week during the resumption program
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 activities in hospital3 month in a resumption program of physical activity in hospital | Other | Hospital program of resumption |
| Physical activity outside hospital3 month in a resumption program of physical activity outside hospital with discovery sessions | Other | Non hospital program of resumption |
Primary outcome
Practice of physical activity
Time frame: 12 month
During a year we follow the physical activity rate with the IPAQ questionary and interviews. With interviews we also question the kind of physical activity.
3 secondary outcomes
Self-reported perceptions of quality of life
Time frame: 12 month
Perceptions of enjoyment in practice of physical activity
Time frame: 12 month
The qualitative motivational criteria of physical activity practice
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 26542533Omorou AY, Langlois J, Lecomte E, Briancon S, Vuillemin A. Cumulative and bidirectional association of physical activity and sedentary behaviour with health-related quality of life in adolescents. Qual Life Res. 2016 May;25(5):1169-78. doi: 10.1007/s11136-015-1172-7. Epub 2015 Nov 6.
- Background: PubMed 15917053Vuillemin A, Boini S, Bertrais S, Tessier S, Oppert JM, Hercberg S, Guillemin F, Briancon S. Leisure time physical activity and health-related quality of life. Prev Med. 2005 Aug;41(2):562-9. doi: 10.1016/j.ypmed.2005.01.006.
- Background: PubMed 26541890Lewis BA, Williams DM, Frayeh A, Marcus BH. Self-efficacy versus perceived enjoyment as predictors of physical activity behaviour. Psychol Health. 2016;31(4):456-69. doi: 10.1080/08870446.2015.1111372. Epub 2015 Nov 18.
- Background: PubMed 20604700Crain AL, Martinson BC, Sherwood NE, O'Connor PJ. The long and winding road to physical activity maintenance. Am J Health Behav. 2010 Nov-Dec;34(6):764-75. doi: 10.5993/ajhb.34.6.11.
- Background: PubMed 18252074Williams NH, Hendry M, France B, Lewis R, Wilkinson C. Effectiveness of exercise-referral schemes to promote physical activity in adults: systematic review. Br J Gen Pract. 2007 Dec;57(545):979-86. doi: 10.3399/096016407782604866.
- Background: PubMed 9817135Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8. doi: 10.1016/s0895-4356(98)00109-7.
- Background: PubMed 2489825McAuley E, Duncan T, Tammen VV. Psychometric properties of the Intrinsic Motivation Inventory in a competitive sport setting: a confirmatory factor analysis. Res Q Exerc Sport. 1989 Mar;60(1):48-58. doi: 10.1080/02701367.1989.10607413.
- Derived from this study: PubMed 35070353Riquier O, Vuillemin A, Van Hoye A. PERSISTE: a mixed methods protocol to identify barriers and levers to a sustainable physical activity practice among patients with chronic disease after physical activity resumption programs. BMJ Open Sport Exerc Med. 2022 Jan 7;8(1):e001261. doi: 10.1136/bmjsem-2021-001261. eCollection 2022.
- Economic impacts of chronic diseases in France, 2018Link provided by the sponsor.
- Disparities in the practice of physical activities in France in 2019Link provided by the sponsor.
- Physical activity : treatment of chronic diseases, a collective expertise of INSERMLink provided by the sponsor.
- Individual participant dataSharing planned: No. All individual informations will be anonymous
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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.
Oriane Odin contact
Olivier Riquier, PhD std principal investigator
Comité Départemental Olympique et Sportif de Seine Saint Denis / Université de Lorraine
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Comité Départemental Olympique et Sportif de Seine Saint Denis.
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 1 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Olivier Riquier, PhD std (+33617333194, olivier.riquier@cdos93.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Practice of physical activity (time frame: 12 month). 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 NCT04954209, which also lists 9 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 8 Jul 2021.