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This is a prospective, randomized, controlled, two parallel arms, single-blind pilot study. In this design, all included patients in the chronic phase of a stroke will receive both modes of physical activity.
This study includes patients over 18 years of age with spastic hemiparesis sequelae of a first unilateral hemispheric stroke older than 6 months and able to walk for 6 minutes. The non-inclusion criteria were the inability to walk without human assistance (with or without technical aids), the existence of cognitive disorders compromising informed consent, in particular the inability to understand the objective and the modalities of the protocol, the inability to communicate with the examiners, and the presence of an additional neurological disorder or a pathology contraindicating the practice of physical activity.
The primary endpoint is based on daily activity measurement by measuring the number of steps per day, collected over the duration of the study, via a Stepwatchâ„¢ device. Secondary end points involve a written physical activity report, assessment of walking ability (via walking-test 6, heart rate, and blood pressure), a measure of perceived exertion, stroke-specific quality of life, balance, and motivation to perform physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First APA program | Experimental | The evaluation of the primary endpoint to meet our main objective will be done at W13 for both groups. The addition of an APA program in autonomy following the structured program for group 1 will make it possible to answer a secondary question focusing on the comparison of the effectiveness of the self-directed program carried out alone or following a structured program. 1st group: D0: Include S1-S12: APA program at IUR Valmante S13: Break S14-S25: APA Autoprogram In addition, the patients in group 1 are maintained in the follow-up to study the maintenance of any observed effect. |
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| Second APA program | Active Comparator | Our study design provides for compensatory participation in the structured program for patients in group 2, following the self-program. From an ethical point of view, this scheme allows all patients included in the structured APA program to benefit. 2nd group: D0: Include S1-S12: APA Autoprogram S13: End of study S14-S25: APA program at IUR Valmante compensatory |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted physical activity program | Other | Rehabilitation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Daily activity measurement | Measuring the number of steps per day, collected over the duration of the study, via a Stepwatch device | through study completion |
| Measure | Description | Time Frame |
|---|---|---|
| the rate physical activities in Written report | carried out by the patient, more or less helped by his close entourage, recorded in a notebook given at the beginning of the study | through study completion |
| 6-minute walk test (6MWT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maeva COTINAT | Contact | 04 91 74 42 00 | maeva.cotinat@ap-hm.fr | |
| Claire MORANDO | Contact | 04 91 38 21 83 | claire.morando@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Médecine Physique et de Réadaptation, CHU Hôpital Sainte Marguerite | Recruiting | Marseille | Bouches du Rhône | 13009 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39032927 | Derived | Satger E, Prieur-Blanc N, Viton JM, Auquier P, Bensoussan L, Cotinat M. Effectiveness of an institution-based adapted physical activity programme versus a home-based self-management programme for chronic poststroke adults: protocol for a randomised controlled study. BMJ Open. 2024 Jul 20;14(7):e084688. doi: 10.1136/bmjopen-2024-084688. |
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Data sharing statements that meet these ICMJE requirements Individual pseudonymous data of participants may be available The data that may be shared are the individual data of the participants which underlie the results reported in this article, after de-identification (text, tables, figures and appendices).
Beginning 3 months and ending 3 years following article publication.
For researchers who provide a methodologically sound proposal. Types of analyses: Achieve the objectives of the approved proposal. Proposals should be sent to maeva.cotinat@ap-hm.fr
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| Adapted physical activity self-program |
| Other |
Rehabilitation |
|
A test validated in the literature that consists of measuring the greatest distance that a subject can travel on a flat surface (30 meter corridor) in 6 minutes.
| at inclusion Day and at the 13th week (and the 26th week for one group only) |
| Measurement of heart rate at rest and after 6-minute walk test | with a blood pressure cuff | at inclusion Day and at the 13th week (and the 26th week for one group only) |
| Measurement of systolic blood pressure at rest and after 6-minute walk test | with a blood pressure cuff | at inclusion Day and at the 13th week (and the 26th week for one group only) |
| Borg Rating Scale of Exertion | test validated in the literature that allows the evaluation of the perception of effort by the patient ; minimum value : 0 = rest : no exertion ; maximum value : 10 = maximal exertion | at inclusion Day and at the 13th week (and the 26th week for one group only) |
| Stroke Specific Quality of Life scale (SS-QoL) | A test validated in French in the literature that assesses the specific quality of life of stroke patients in 49 items ; minimum value : 1 = Total help/ Couldn't do it at all/ Strongly agree ; maximum value : 5 = No help needed/ No trouble at all/ Strongly disagree | at inclusion Day and at the 13th week (and the 26th week for one group only) |
| Berg Balance Scale (BBS) | validated scale allowing, by means of 14 instructions, an evaluation of balance, reproducible and sensitive to change ; minimum score : 0-20 = high risk of falling ; maximal score : 56 = no risk of falling | at inclusion Day and at the 13th week (and the 26th week for one group only) |
| Activity-specific Balanced Confidence scale (ABC scale) | French language validated scale assessing the patient's confidence in his or her balance, using 16 situations where the subject is asked to rate his or her balance on a numerical scale ; minimal rate : 0% = not at all confident ; maximal rate : 100% = completely confident | at inclusion Day and at the 13th week (and the 26th week for one group only) |
| Behavioral regulation in exercise questionnaire | scale used in the literature to assess motivation to perform physical activity ; minimal value : 1 = not true at all ; maximal value : 7 = absolutely true | at inclusion Day and at the 13th week (and the 26th week for one group only) |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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