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Telerehabilitation for Dysautonomia in Parkinson's Disease (PKT)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hybrid telerehabilitation program
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring virtual rehabilitation, exercise, parkinsonism, cardiovascular, autonomic nervous system, cardiorespiratory, physical therapy, physiotherapy, physical activity

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre de Recherche sur le VieillissementRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Group of participants receiving the hybrid telerehabilitation intervention

Outcomes

Primary Outcome Measures

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).
Fidelity
The measurement of fidelity will involve tracking the frequency of significant modifications made to the planned protocol. These alterations include changes in the exercise order, the introduction of additional exercises not originally part of the program, and variations in session duration and completion of educational components.
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.
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).
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.
Exercise capacity
Six-minute walk test (performance and physiological responses)

Secondary Outcome Measures

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.
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.
Perceived quality of life
Parkinson's Disease Questionnaire 8 items (PDQ-8, scored 0-32, higher score indicating the worst quality of life)
Lower-limb function
Lower Extremity Functional Scale (LEFS, scored 0-32, higher score indicating less difficulty)
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)
Mobility
Timed Up and Go
Balance
Berg balance scale (scored 0-56, higher score indicating more balance)
Walking capacity
10-meter walk test
Lower-limb strength and power
5-repetition sit to stand test
Fine motor dexterity and coordination
Purdue Pegboard Test
Cardiovascular health
24-hour ambulatory blood pressure monitoring (Mobil-O-Graph® 24hr ABPM) (systolic and diastolic blood pressure)
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).
Autonomic modulation
Heart rate variability (HRV) (supine 6 minutes and upright position 6 minutes)

Full Information

First Posted
August 8, 2023
Last Updated
August 23, 2023
Sponsor
Université de Sherbrooke
Collaborators
Centre de Recherche sur le Vieillissement (CdRV)
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1. Study Identification

Unique Protocol Identification Number
NCT06017232
Brief Title
Telerehabilitation for Dysautonomia in Parkinson's Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Centre de Recherche sur le Vieillissement (CdRV)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
virtual rehabilitation, exercise, parkinsonism, cardiovascular, autonomic nervous system, cardiorespiratory, physical therapy, physiotherapy, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study design is a pre-post without a control group
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Group of participants receiving the hybrid telerehabilitation intervention
Intervention Type
Other
Intervention Name(s)
Hybrid telerehabilitation program
Other Intervention Name(s)
OpenTera telerehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the implementation
Description
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).
Time Frame
12 weeks
Title
Fidelity
Description
The measurement of fidelity will involve tracking the frequency of significant modifications made to the planned protocol. These alterations include changes in the exercise order, the introduction of additional exercises not originally part of the program, and variations in session duration and completion of educational components.
Time Frame
12 weeks
Title
Acceptability
Description
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.
Time Frame
12 weeks
Title
Dysautonomia Symptoms
Description
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).
Time Frame
12 weeks
Title
Impact of dysautonomia symptoms
Description
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.
Time Frame
12 weeks
Title
Exercise capacity
Description
Six-minute walk test (performance and physiological responses)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Severity of pain and impact on functioning
Description
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.
Time Frame
12 weeks
Title
Type of pain
Description
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.
Time Frame
12 weeks
Title
Perceived quality of life
Description
Parkinson's Disease Questionnaire 8 items (PDQ-8, scored 0-32, higher score indicating the worst quality of life)
Time Frame
12 weeks
Title
Lower-limb function
Description
Lower Extremity Functional Scale (LEFS, scored 0-32, higher score indicating less difficulty)
Time Frame
12 weeks
Title
Mobility in the community
Description
Life-space mobility (French-Canadian version) (partial scores are summed to produce a composite score 0-120, higher score indicating more mobility)
Time Frame
12 weeks
Title
Mobility
Description
Timed Up and Go
Time Frame
12 weeks
Title
Balance
Description
Berg balance scale (scored 0-56, higher score indicating more balance)
Time Frame
12 weeks
Title
Walking capacity
Description
10-meter walk test
Time Frame
12 weeks
Title
Lower-limb strength and power
Description
5-repetition sit to stand test
Time Frame
12 weeks
Title
Fine motor dexterity and coordination
Description
Purdue Pegboard Test
Time Frame
12 weeks
Title
Cardiovascular health
Description
24-hour ambulatory blood pressure monitoring (Mobil-O-Graph® 24hr ABPM) (systolic and diastolic blood pressure)
Time Frame
12 weeks
Title
Sympathetic nervous innervation of the skin
Description
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).
Time Frame
12 weeks
Title
Autonomic modulation
Description
Heart rate variability (HRV) (supine 6 minutes and upright position 6 minutes)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Livia Pinheiro Carvalho, PhD
Phone
819 780-2220
Ext
71095
Email
livia.pinheiro.carvalho@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Leo Crepin, MSc(cand)
Email
leo.crepin@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia Pinheiro Carvalho, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche sur le Vieillissement
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Laperle
Phone
819 780-2220
Ext
45132
Email
direction-cdrv@usherbrooke.ca

12. IPD Sharing Statement

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Telerehabilitation for Dysautonomia in Parkinson's Disease

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