Engage-PD: a Physical Activity Coaching Program Via Telehealth for People With Parkinson's Disease. A Single-cohort Study in Spain. (EngagePD-BCN)
Engage-PD is a single cohort evaluation of implementation of a telehealth-delivered physical activity coaching program for people with early-mid stage Parkinson's disease in Spanish population. The program utilizes a physiotherapist to provide one-on-one coaching for individuals with early-mid stage Parkinson's disease to provide individualized structured support to facilitate and optimize exercise uptake as part of an effective self-management program.
BACKGROUND: Parkinson's disease is a progressive neurodegenerative condition for which there is currently no cure. Physical activity and exercise have demonstrated benefits for motor and non-motor symptoms, functional performance, and brain structure and function. Exercise, particularly at higher intensities, may also provide neuroprotective and neurorestorative effects and may be especially important during the early stages of the disease. Despite these potential benefits, people with Parkinson's disease are substantially less active than healthy adults, and physical activity declines as the disease progresses. Perceived barriers, including low expectations of exercise benefits, limited time, fear of falling, and lack of motivation, may contribute to reduced participation. Despite this, there is limited research examining interventions specifically designed to increase and maintain aerobic exercise.
OBJECTIVE: This study aims to investigate the feasibility and acceptability of a theory-based behavioural change program designed to increase aerobic exercise participation in Spanish population. The study will also examine whether the intervention can improve exercise self-efficacy and motivation and reduce perceived barriers to physical activity.
METHODOLOGY: A single cohort of people with Parkinson's disease in the stages of Hoehn and Yahr I-III who are willing to participate in the 3-month Engage-PD program, which consisted of up to 5 telehealth coaching sessions delivered by a trained physical therapist expert in Parkinson's disease. Feasibility is evaluated based on recruitment and retention rates, along with participants' feedback. Planned and unplanned physical activity, exercise self-efficacy, and individualized goals are assessed pre- and post-intervention. Relationships between baseline characteristics and changes in planned PA and ESE are also evaluated.
SIGNIFICANCE: A behavioural change program that integrates instrumental, emotional, and informational support may help individuals with early-stage Parkinson's disease establish sustainable exercise habits and incorporate physical activity into daily routines. Physiotherapists may play an important role in supporting these behavioural changes by addressing physical performance, self-management, cognitive-behavioural strategies, and environmental factors that influence participation in exercise.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Individuals will be recruited through the Movement disorders database from Hospital Clinic de Barcelona as one of the reference centers in Catalonia (Spain). Individuals who choose to participate will first be given a brief evaluation, including history and contraindications for exercise, assessment of gait and balance, physical activity questionnaire (Brunel Lifestyle Inventory and International Physical Activity Questionnaire), pain questionnaire (Brief Pain Inventory), NeuroQOL quality of life assessment, and a self-efficacy measure about exercise engagement (Exercise Self Efficacy Scale). For those individuals who report low back pain, we will further administer the Modified Oswestry Low Back Pain Disability Questionnaire and a customized low back pain questionnaire. The physiotherapist will then conduct the coaching session (see below). If this assessment is not able to be conducted in person, it will be conducted via secure videoconferencing. There will be between 1-4 follow-up phone call/videosessions and a follow-up assessments at 3 months and 6 months where all assessment will be repeated. A short questionnaire will also be administered at 3 and 6 months to assess the acceptability of the intervention.
The coaching program will utilize the Pre-Active PD program (Clinicaltrials.gov NCT03696589) to guide the delivery of the intervention. This will include a checklist of the key elements that are important for the therapist in order to facilitate PA behavior change. In addition, the therapist will utilize motivational interviewing strategies that include four processes (engaging, evoking, planning, and tracking) and five core communication skills (asking open ended questions, affirming, reflective listening, summarizing, and informing and advising). The therapist will introduce the Pre-Active PD workbook and utilize it as a tool and reference for the participant in order to engage and focus them throughout the coaching process, and will educate participants on the types of exercise options and the specific exercise benefits for PD. In the planning process, the therapist will facilitate discussion on development of specific and measurable goals, and will provide options for tracking their progress, such as written or web-based exercise logs or an activity monitor. The recommended exercises will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate-vigorous intensity aerobic exercise a minimum of three times per week. Balance and strengthening exercises will also be recommended as appropriate. At the follow up sessions (15-30 min), the therapist will review progress with the current exercise plan and progress, record if any falls have occurred and discuss barriers and facilitators for exercise engagement. Participants will also be given a short exercise safety checklist to assure safety when conducting home exercises. Participants will have the option to use a Fitbit device (Charge 6) to monitor their heart rate and physical activity during the course of the intervention period. Participants will use a study-specific login to track their progress and activity. Participants who already own a Fitbit or other activity monitor can continue to use their device during the study.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Selma Pelaez Selma Peláez Hervás
- Numer telefonu: +34616726022
- E-mail: spelaez@clinic.cat
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Neurologist confirmed clinical diagnosis for Parkinson's disease Hoehn & Yahr stage I-III
- Ambulatory for indoor and outdoor mobility without assistance or assistive device
- Successful completion of Physical Activity Readiness Questionnaire (PAR-Q)26 or medical clearance from GP
Exclusion Criteria:
- Musculoskeletal injury that would prevent participation in an exercise program.
- Other neurological disease or disorder such as stroke
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Physical Activity Coaching
Participants will receive up to 5 coaching sessions by a physical or occupational therapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit or other device to monitor their heart rate and physical activity during the course of the intervention period. |
Participants will receive up to 5 coaching sessions by a physiotherapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit charge 6 or other device to monitor their heart rate and physical activity during the course of the intervention period. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Brunel Lifestyle Physical Activity Questionnaire
Ramy czasowe: 3 months
|
The Brunel lifestyle inventory is a 10-item questionnaire that measures both pre-planned (6 items) and un-planned (3 items) lifestyle PA. Scoring for each item is on a scale of 1-5, and the scores for each subscale are averaged. Scores range from 1 (low level of physical activity) to 5 (high level of physical activity). |
3 months
|
|
Self-Efficacy for Exercise Scale
Ramy czasowe: 3 months
|
18-item test that measures an individual's self-efficacy to participate in exercise when numerous barriers are present, including both social and physical barriers. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise. |
3 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
International Physical Activity Questionnaire (Short-Form Phone version)
Ramy czasowe: 3 months
|
Evaluates physical activity over the previous 7 days represented in MET/min per week with higher values meaning greater physical activity. |
3 months
|
|
NeuroQOL
Ramy czasowe: 3 months
|
Patient-reported questionnaire evaluating sleep disturbances, depression, fatigue and social participation and satisfaction. |
3 months
|
|
Brief Pain Inventory
Ramy czasowe: 3 months
|
Evaluates the presence of pain including intensity and interference with activities of daily living. Mean of the four severity items is used as measures of pain severity; the mean of the seven interference items is used as a measure of pain interference. |
3 months
|
|
Timed Up and Go
Ramy czasowe: 3 months
|
Performance-based assessment which requires a person to stand up from a chair, walk 10 feet, turn around, return to their chair and sit back down. Outcome is measured in time (sec) to complete and higher value is worse performance. |
3 months
|
|
Standing balance assessment
Ramy czasowe: 3 months
|
Participant will perform static standing with feet together and postural sway will be recorded with a smartphone app. |
3 months
|
|
Modified Oswestry Low Back Pain Disability Questionnaire
Ramy czasowe: 3 months
|
Questionnaire evaluating how back pain affects everyday life (optional for those participants who report low back pain). Range 0-50 with 50 being higher level of disability. |
3 months
|
|
Acceptability questionnaire (open-ended questions)
Ramy czasowe: 3 months
|
A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively. |
3 months
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- EngagePD-Barcelona
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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