PARKINSON DISEASE (Disorder)EngagePD-BCNNCT07859332
Engage-PD: a Physical Activity Coaching Program Via Telehealth for People With Parkinson's Disease. A Single-cohort Study in Spain.
A study testing Physical Activity Coaching in people with PARKINSON DISEASE (Disorder), run by Hospital Clinic of Barcelona.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Physical Activity Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Musculoskeletal injury that would prevent participation in an exercise program.
- Other neurological disease or disorder such as stroke
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Physical Activity Coaching
- Keywords
- physical activity, exercise, rehabilitation
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Coaching | Experimental | 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. Receives: Behavioral: Physical Activity Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brunel Lifestyle Physical Activity Questionnaire
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).
Measured: 3 months
Self-Efficacy for Exercise Scale
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.
Measured: 3 months
Secondary outcomes (7)
International Physical Activity Questionnaire (Short-Form Phone version)
Evaluates physical activity over the previous 7 days represented in MET/min per week with higher values meaning greater physical activity.
Measured: 3 months
NeuroQOL
Patient-reported questionnaire evaluating sleep disturbances, depression, fatigue and social participation and satisfaction.
Measured: 3 months
Brief Pain Inventory
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.
Measured: 3 months
Timed Up and Go
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.
Measured: 3 months
Standing balance assessment
Participant will perform static standing with feet together and postural sway will be recorded with a smartphone app.
Measured: 3 months
Modified Oswestry Low Back Pain Disability Questionnaire
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.
Measured: 3 months
Acceptability questionnaire (open-ended questions)
A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startJun 2027 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Behavioral: Physical Activity Coaching.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859332
- Sponsor's protocol ID
- EngagePD-Barcelona
- Acronym
- EngagePD-BCN
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engage-PD: a Physical Activity Coaching Program Via Telehealth for People With Parkinson's Disease. A Single-cohort Study in Spain.
- ClinicalTrials.gov ID
- NCT07859332
- Acronym / sponsor ID
- EngagePD-BCN / EngagePD-Barcelona
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- physical activity, exercise, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- Jun 2027 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Behavioral: Physical Activity Coaching.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Coaching | Experimental | Behavioral: Physical Activity CoachingParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Musculoskeletal injury that would prevent participation in an exercise program.
- Other neurological disease or disorder such as stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity CoachingParticipants 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. | Behavioural | Physical Activity Coaching |
Primary outcome
Brunel Lifestyle Physical Activity Questionnaire
Time frame: 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).
Self-Efficacy for Exercise Scale
Time frame: 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.
7 secondary outcomes
International Physical Activity Questionnaire (Short-Form Phone version)
Time frame: 3 months
NeuroQOL
Time frame: 3 months
Brief Pain Inventory
Time frame: 3 months
Timed Up and Go
Time frame: 3 months
Standing balance assessment
Time frame: 3 months
Modified Oswestry Low Back Pain Disability Questionnaire
Time frame: 3 months
Acceptability questionnaire (open-ended questions)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Coaching in people with PARKINSON DISEASE (Disorder), run by Hospital Clinic of Barcelona.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selma Pelaez Selma Peláez Hervás (+34616726022, spelaez@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brunel Lifestyle Physical Activity Questionnaire (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.