Comparison of the Effectiveness of an Adapted Physical Activity Program in a Dedicated Structure to a Self-program in Patients in Chronic Phase of a Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Adapted physical activity program
- Conditions
- Stroke
- Sponsor
- Assistance Publique Hopitaux De Marseille
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Daily activity measurement
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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 Stepwatch™ 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age greater than 18 years
- •Left or right spastic hemiparesis after a first hemorrhagic or ischemic unilateral stroke older than 6 months
- •Walking possible for 6 minutes
Exclusion Criteria
- •Inability to walk without human assistance (with or without technical aids)
- •Cognitive impairment that compromises informed consent, including inability to understand the purpose and terms of the protocol
- •Inability to communicate
- •Presence of an additional neurological disorder
- •Medical conditions that contraindicate physical activity, such as an unbalanced cardiovascular or respiratory condition
- •Concurrent participation in another clinical research project
Arms & Interventions
First APA program
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.
Intervention: Adapted physical activity program
Second APA program
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
Intervention: Adapted physical activity self-program
Outcomes
Primary Outcomes
Daily activity measurement
Time Frame: through study completion
Measuring the number of steps per day, collected over the duration of the study, via a Stepwatch device
Secondary Outcomes
- the rate physical activities in Written report(through study completion)
- Berg Balance Scale (BBS)(at inclusion Day and at the 13th week (and the 26th week for one group only))
- Stroke Specific Quality of Life scale (SS-QoL)(at inclusion Day and at the 13th week (and the 26th week for one group only))
- Activity-specific Balanced Confidence scale (ABC scale)(at inclusion Day and at the 13th week (and the 26th week for one group only))
- 6-minute walk test (6MWT)(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(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(at inclusion Day and at the 13th week (and the 26th week for one group only))
- Borg Rating Scale of Exertion(at inclusion Day and at the 13th week (and the 26th week for one group only))
- Behavioral regulation in exercise questionnaire(at inclusion Day and at the 13th week (and the 26th week for one group only))