Clinical trial NCT06017232: Telerehabilitation for Dysautonomia in Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: virtual rehabilitation
exercise
parkinsonism
cardiovascular
autonomic nervous system
cardiorespiratory
physical therapy
physiotherapy
physical activity
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Centre de Recherche sur le Vieillissement (CdRV)
First posted: 2023-08-30
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is a pre-post without a control group
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients with PD (1 to 3 on Hoeh\&Yahr)
* Patients under treatment with optimized drug therapy. Medication is stable for at least 1 month
* Patients with access to the internet
* Speaking French or English
* 50 years or older
* Patients having cardiovascular dysautonomia according to the clinical criteria: supine hypertension (SH) (≥140/90 mmHg) and/or orthostatic hypotension (OH) (a drop of systolic blood pressure ≥ 20 mmHg and/or diastolic blood pressure ≥ 10 mmHg during the active orthostatic hypotension test).

Exclusion Criteria:

* Major cognitive impairment (Montreal Cognitive Assessment, score ≤ 24)
* Neurological disorders other than PD
* Musculoskeletal or cardiopulmonary disorders preventing physical activity, contraindication to physical activity, or presence of a cardiac pacemaker.

Primary outcomes:
measure: Feasibility of the implementation
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
measure: Dysautonomia Symptoms
timeFrame: 12 weeks
measure: Impact of dysautonomia symptoms
timeFrame: 12 weeks
measure: Exercise capacity
timeFrame: 12 weeks
Secondary outcomes:
measure: Severity of pain and impact on functioning
timeFrame: 12 weeks
measure: Type of pain
timeFrame: 12 weeks
measure: Perceived quality of life
timeFrame: 12 weeks
measure: Lower-limb function
timeFrame: 12 weeks
measure: Mobility in the community
timeFrame: 12 weeks
measure: Mobility
timeFrame: 12 weeks
measure: Balance
timeFrame: 12 weeks
measure: Walking capacity
timeFrame: 12 weeks
measure: Lower-limb strength and power
timeFrame: 12 weeks
measure: Cardiovascular health
timeFrame: 12 weeks
measure: Sympathetic nervous innervation of the skin
timeFrame: 12 weeks
measure: Autonomic modulation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de Recherche sur le Vieillissement
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Livia Pinheiro Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References: