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

NCT06061770 | Recruiting

• 1 other identifier: RCAPHM21_0439
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Daily activity measurement

  Measuring the number of steps per day, collected over the duration of the study, via a Stepwatch device

  through study completion

Secondary Outcomes (9)

• the rate physical activities in Written report

  through study completion

• 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)

Study Arms (2)

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.

Other: Adapted physical activity program

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

Other: Adapted physical activity self-program

Interventions

Adapted physical activity program OTHER

Rehabilitation

First APA program

Adapted physical activity self-program OTHER

Rehabilitation

Second APA program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Médecine Physique et de Réadaptation, CHU Hôpital Sainte Marguerite

Marseille, Bouches du Rhône, 13009, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 39032927 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 29, 2023
• Study Start: September 27, 2024
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): March 26, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 3 years following article publication.
• Access Criteria: 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

Locations

FR (1)