Clinical trial NCT06061770: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Daily activity measurement
timeFrame: through study completion
Secondary outcomes:
measure: the rate physical activities in Written report
timeFrame: through study completion
measure: 6-minute walk test (6MWT)
timeFrame: at inclusion Day and at the 13th week (and the 26th week for one group only)
measure: Measurement of heart rate at rest and after 6-minute walk test
timeFrame: at inclusion Day and at the 13th week (and the 26th week for one group only)
measure: Measurement of systolic blood pressure at rest and after 6-minute walk test
timeFrame: at inclusion Day and at the 13th week (and the 26th week for one group only)
measure: Borg Rating Scale of Exertion
timeFrame: at inclusion Day and at the 13th week (and the 26th week for one group only)
measure: Stroke Specific Quality of Life scale (SS-QoL)
timeFrame: at inclusion Day and at the 13th week (and the 26th week for one group only)
measure: Berg Balance Scale (BBS)
timeFrame: at inclusion Day and at the 13th week (and the 26th week for one group only)
measure: Activity-specific Balanced Confidence scale (ABC scale)
timeFrame: at inclusion Day and at the 13th week (and the 26th week for one group only)
measure: Behavioral regulation in exercise questionnaire
timeFrame: at inclusion Day and at the 13th week (and the 26th week for one group only)
Other outcomes:
Locations:
city: Marseille
country: France
facility: Médecine Physique et de Réadaptation, CHU Hôpital Sainte Marguerite
state: bouches du Rhône
Study officials:
References: