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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Selma Pelaez Selma Peláez Hervás
- 電話番号：+34616726022
- メール：spelaez@clinic.cat
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Brunel Lifestyle Physical Activity Questionnaire
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
International Physical Activity Questionnaire (Short-Form Phone version)
時間枠：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
時間枠：3 months
|
Patient-reported questionnaire evaluating sleep disturbances, depression, fatigue and social participation and satisfaction. |
3 months
|
|
Brief Pain Inventory
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：3 months
|
A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively. |
3 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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