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Parkinson DiseasePKTNCT06017232

Telerehabilitation for Dysautonomia in Parkinson's Disease

A study testing Hybrid telerehabilitation program in people with Parkinson Disease, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Hybrid telerehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteCanada
Study dates
13 Jun 2023to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre de Recherche sur le Vieillissement

    Sherbrooke, Quebec, J1H 4C4

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Hybrid telerehabilitation program
Keywords
virtual rehabilitation, exercise, parkinsonism, cardiovascular, autonomic nervous system, cardiorespiratory, physical therapy, physiotherapy, physical activity
Medical subject headings
Parkinson Disease, Motor Activity, Parkinsonian Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hybrid telerehabilitation programOther

    Also called OpenTera telerehabilitation

    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.

Study groups in NCT06017232
Study groupRoleWhat they receive
Intervention groupExperimentalGroup of participants receiving the hybrid telerehabilitation intervention
Receives: Other: Hybrid telerehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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).

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. Exercise capacity

    Six-minute walk test (performance and physiological responses)

    Measured: 12 weeks

Secondary outcomes (12)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. Perceived quality of life

    Parkinson's Disease Questionnaire 8 items (PDQ-8, scored 0-32, higher score indicating the worst quality of life)

    Measured: 12 weeks

  4. Lower-limb function

    Lower Extremity Functional Scale (LEFS, scored 0-32, higher score indicating less difficulty)

    Measured: 12 weeks

  5. 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)

    Measured: 12 weeks

  6. Mobility

    Timed Up and Go

    Measured: 12 weeks

  7. Balance

    Berg balance scale (scored 0-56, higher score indicating more balance)

    Measured: 12 weeks

  8. Walking capacity

    10-meter walk test

    Measured: 12 weeks

  9. Lower-limb strength and power

    5-repetition sit to stand test

    Measured: 12 weeks

  10. Cardiovascular health

    24-hour ambulatory blood pressure monitoring (Mobil-O-Graph® 24hr ABPM) (systolic and diastolic blood pressure)

    Measured: 12 weeks

  11. 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).

    Measured: 12 weeks

  12. Autonomic modulation

    Heart rate variability (HRV) (supine 6 minutes and upright position 6 minutes)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start13 Jun 2023
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study design is a pre-post without a control group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06017232
Sponsor's protocol ID
20224665
Acronym
PKT
Status last verified
May 2024
First submitted
8 Aug 2023
Last updated
23 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hybrid telerehabilitation program in people with Parkinson Disease, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the implementation (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06017232.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.

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