Telerehabilitation for Dysautonomia in Parkinson's Disease

NCT06017232 | Completed

• 1 other identifier: 20224665
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

virtual rehabilitation; exercise; parkinsonism; cardiovascular; autonomic nervous system; cardiorespiratory; physical therapy; physiotherapy; physical activity

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Exercise capacity

  Six-minute walk test (performance and physiological responses)

  12 weeks

Secondary Outcomes (12)

• Severity of pain and impact on functioning

  12 weeks

• Type of pain

  12 weeks

• Perceived quality of life

  12 weeks

• Lower-limb function

  12 weeks

• Mobility in the community

  12 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

Group of participants receiving the hybrid telerehabilitation intervention

Other: Hybrid telerehabilitation program

Interventions

Hybrid telerehabilitation program OTHER

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.

Also known as: OpenTera telerehabilitation

Intervention group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Centre de Recherche sur le Vieillissement (CdRV): collaborator

Study Sites (1)

Centre de Recherche sur le Vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Livia Pinheiro Carvalho, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a pre-post without a control group

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 30, 2023
• Study Start: June 13, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

CA (1)