Telerehabilitation for Dysautonomia in Parkinson's Disease

Parkinson Disease Clinical Trial

— PKT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06017232
• Other study ID #: 20224665
• Status: Completed
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Parkinson Disease
• Primary Dysautonomias

Intervention

Other:
• Hybrid telerehabilitation program
The telerehabilitation program lasts 12 week (3 per week). The program includes aerobic, strength, coordination, balance, flexibility, and breathing exercises, in addition to educational components focused on disease management. This hybrid program incorporates both supervised and unsupervised sessions. A progressive approach from synchronous (supervised) to asynchronous (unsupervised) sessions is adopted. Each session is structured into 4 components: Warm-up; Muscle strengthening, coordination, and balance; Flexibility; and Breathing exercises. Participants are asked to maintain a log of their aerobic activity, recording details such as the type of activity, duration, and intensity. The aim is to align with the recommended aerobic physical activity guidelines (150 min/week). Weekly assessments are conducted to provide personalized guidance based on individual progress. Also, participants engage in weekly educational videos that cover a diverse range of PD-related topics.

Locations

Country	Name	City	State
Canada	Centre de Recherche sur le Vieillissement	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Centre de Recherche sur le Vieillissement (CdRV)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the implementation	This will be evaluated by the percentage of participants that accepted to participate in the study (recruitment rate), percentage who completed the intervention (retention rate) and number of completed session in relation to the anticipated number of sessions (adherence).	12 weeks
Primary	Acceptability	The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.	12 weeks
Primary	Dysautonomia Symptoms	Scale for Outcomes in Parkinson's disease for Autonomic symptoms (SCOPA-AUT) with maximum score 69, with the score for each item ranging from 0 (never experiencing the symptom) to 3 (often experiencing the symptom).	12 weeks
Primary	Impact of dysautonomia symptoms	Orthostatic Hypotension Questionnaire (OHQ): The questionnaire is divided into 2 parts: Part I, Symptom Assessment (OHSA), consisted of 6 questions, each rat-ing the intensity of one characteristic symptom [ 1. Dizziness, lightheadedness, feeling faint, or feeling Iike you might black out; 2. Problems with vision (blurring, seeing spots, tunnel vision, etc.); 3. Generalized weakness; 4. Fatigue; 5. Trouble concentrating; 6. Head/neck dis-comfort] and Part Il, Daily Activity Scale (OHDAS), consisted of 4 questions that assessed the impact of NOH symptoms on daily activities.; Items scored on an 11-point scale (0 to 10), with O indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference. The composite OHQ score is calculated by averaging the OHSAS and the OHDAS.	12 weeks
Primary	Exercise capacity	Six-minute walk test (performance and physiological responses)	12 weeks
Secondary	Severity of pain and impact on functioning	Brief Pain Inventory: Participants are asked to rate their current symptoms, their average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 0 to 10. A total pain severity score can be found by averaging these items or a single item can be treated as the primary outcome measure.	12 weeks
Secondary	Type of pain	Neuropathic pain DN4 Questionnaire: Items are scored based on a yes (1 point) /no (0 points) answer. This leads to a score range of 0-10 when the symptoms (range 0-7 points) as well as the signs (range 0-3 points) items are included.	12 weeks
Secondary	Perceived quality of life	Parkinson's Disease Questionnaire 8 items (PDQ-8, scored 0-32, higher score indicating the worst quality of life)	12 weeks
Secondary	Lower-limb function	Lower Extremity Functional Scale (LEFS, scored 0-32, higher score indicating less difficulty)	12 weeks
Secondary	Mobility in the community	Life-space mobility (French-Canadian version) (partial scores are summed to produce a composite score 0-120, higher score indicating more mobility)	12 weeks
Secondary	Mobility	Timed Up and Go	12 weeks
Secondary	Balance	Berg balance scale (scored 0-56, higher score indicating more balance)	12 weeks
Secondary	Walking capacity	10-meter walk test	12 weeks
Secondary	Lower-limb strength and power	5-repetition sit to stand test	12 weeks
Secondary	Cardiovascular health	24-hour ambulatory blood pressure monitoring (Mobil-O-Graph® 24hr ABPM) (systolic and diastolic blood pressure)	12 weeks
Secondary	Sympathetic nervous innervation of the skin	Electrodermal activity (Galvanic skin response) with PowerLab ADInstruments: Results are presented as the difference between the maximum of the electrodermal response (or of sweating, therefore of skin conductivity) and the minimum of the electrodermal response (delta values).	12 weeks
Secondary	Autonomic modulation	Heart rate variability (HRV) (supine 6 minutes and upright position 6 minutes)	12 weeks