Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT06017232
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2023-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telerehabilitation for Dysautonomia in Parkinson's Disease
Sponsor:
Université de Sherbrooke
Organization:
Study Overview
Official Title:
The ParkinSANTÉlé Study: A Multicomponent Telerehabilitation Program to Improve Cardiovascular Health in People With Parkinson's Disease With a Clinical Diagnosis of Dysautonomia
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PKT
Brief Summary:
People diagnosed with Parkinson's Disease (PD) exhibit a combination of motor and non-motor symptoms, with the latter posing challenges in terms of identification and management. These non-motor symptoms tend to manifest before the motor symptoms and progressively worsen over time, significantly impacting the symptoms and everyday life activities of those affected. However, there remains a noticeable lack of scientific literature addressing the assessment and rehabilitation of cardiovascular dysautonomia in PD patients. Thus, our research aims to address this gap by pursuing the following objectives: 1) assess the feasibility, acceptability, and potential effectiveness of a hybrid telerehabilitation program designed to target cardiovascular health in individuals with Parkinson's disease; and 2) characterize cardiovascular dysautonomia using non-invasive measurements of cardiovascular and autonomic nervous system (ANS) function and self-reported symptom assessments.
Detailed Description:
This pilot clinical trial employs mixed methods and aims to recruit 16 participants meeting the criteria of stage 1 to 3 Parkinson's disease according to the Hoehn and Yahr scale, aged 50 or above, under optimized drug therapy, having home internet access, and without exercise contraindications, but exhibiting cardiovascular dysautonomia based on positive clinical results from active orthostatic hypotension maneuver, with or without reported symptoms and/or SCOPA-AUT questionnaire score ≥ 2/3 items. The 12-week telerehabilitation program comprises three weekly sessions, encompassing different exercise modalities to improve walk capacity (aerobic, strength, balance, coordination, flexibility) and education on symptom management. A progressive increase in autonomy is implemented, starting with synchronous/asynchronous sessions of 3/0 in week 1 to 0/3 in week 12. Feasibility (recruitment, adherence, retention), acceptability (questionnaire, semi-structured interviews), and potential effectiveness on motor (walking, mobility, balance) and non-motor aspects (pain and cardiovascular dysautonomia) will be measured before and after the intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: