NCT06962930

Brief Summary

Regular exercise can improve function and quality of life as well as have other positive behavioral and health-related benefits in people Parkinson's disease (PD). Despite the benefits, insufficient exercise is common among PD individuals, often due to common barriers, emphasizing the importance of empowering individuals with adequate knowledge and self-management skills. This project aims to develop "Engage-Qatar PD," an online physical activity self-management program for people with PD in Qatar. Engage-Qatar PD will be grounded in a previously developed coaching intervention used in people with Huntington's disease (Engage HD) and people with PD. The main focus of this project will be the development work to adapt this intervention for online delivery for people with PD and within the Qatari context. This development stage will entail participatory design, in which users will be actively involved as co-designers to ensure fully the required cultural adaptations. Following this development phase, a pilot randomized controlled trial will be conducted to assess the feasibility, acceptability, and potential benefits of the developed intervention. The innovative approach proposed for this project would have wide-reaching impact, advancing the development of new therapeutic options. It will deliver a realistic, culturally adapted therapeutic option for people with PD in Qatar that has the potential to be implemented in a variety of healthcare settings and other countries in the region. Importantly, future work could replicate this program in a larger cohort of individuals with other neurodegenerative diseases and extend this work to other countries in the region.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
4mo left

Started Sep 2025

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

April 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 10, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

April 30, 2025

Last Update Submit

September 23, 2025

Conditions

Keywords

PD: Parkinson's Disease PA: Physical Activity NDD: Neuro Degenerative Disease QRI: Qatar Rehabilitation Institute

Outcome Measures

Primary Outcomes (1)

  • Objective Physical activity

    7 day physical activity (i.e., moderate/vigorous activity minutes) using a waist-worn activity monitor (Actigraph)

    7 days

Secondary Outcomes (21)

  • The Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)

    less than 5 minutes

  • International Physical Activity Questionnaire (IPAQ) short form

    5 minutes

  • Six-Minute Walk Test (6MWT)

    10 minutes

  • The Short Self-Efficacy for Exercise Scale (SSEE)

    5 minutes

  • 8-item Parkinson's Disease Questionnaire (PDQ-8)

    5-10 minutes

  • +16 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

Participants will receive an 8-week personalized self-management program. They will be invited to one to 4 face-to-face coaching sessions and 7 remote online sessions. The first session will lay the groundwork for the program, in which an orientation of the features of the online forum will be provided. In addition, goal setting, use of smart watch to record progress, and how to track progress will be discussed. During the remote sessions, the participant and coach will work through informational modules of how to overcome barriers to exercise engagement and how to manage PD symptoms. The coach will provide encouragement in relation to regular physical activity and exercise, and the participant will report on progress related to goals they developed. All participants will receive a wearable watch to help them monitor their physical activity; although wearing the watch is optional, we will recommend that all participants wear it for the 12-week intervention.

Other: 8-week personalized self-management program tailored to their individual needs using Engage-Qatar PD. participants will be invited to one face-to-face coaching session and 7 online sessions

Control group

ACTIVE COMPARATOR

Participants in the control group will receive information on the published recommendations for physical activity for people with PD43. This is the standard information related to physical activity that an individual with PD would be expected to receive from their healthcare provider. To control for the ubiquitous nature of technology, all control participants will also receive Fitbit watches with basic instructions for monitoring their levels of physical activity. As in the intervention group, use of the Fitbit is optional, though we will recommend that both groups wear it for the 8-week intervention. The key ingredients of Engage-Qatar PD are the personalized coaching and self-management approach; thus, the control group will not have access to the Engage-Qatar PD online forum, nor will they have access to coaching or any component of the self-management approach.

Other: 8-week personalized self-management program tailored to their individual needs using Engage-Qatar PD. participants will be invited to one face-to-face coaching session and 7 online sessions

Interventions

The first session will lay the groundwork for the program, in which an orientation of the features of the online forum will be provided. In addition, goal setting, use of watches, and how to track progress will be discussed. During the remote sessions, the participant and coach will work through informational modules of how to overcome barriers to exercise engagement and how to manage PD symptoms. In addition, the coach will provide encouragement in relation to regular physical activity and exercise, and the participant will report on progress related to up to three realistic and individualized goals they developed. key elements: (1) participant-therapist interaction, (2) online forum featuring a physical activity guidebook and workbook, (3) an online platform with personal physical activity database, (4) a wearable smart watch for activity monitors, (5) a video exercise library, (6) online support group, and (7) incorporate adaptation to Arabic culture and available in Arabic

Control groupintervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18 years.
  • Successful completion of Physical Activity Readiness Questionnaire (PAR-Q), or medical clearance from a neurologist.
  • Ambulatory for indoor and outdoor mobility with or without an assistive device but without physical assistance.
  • A neurologist-confirmed diagnosis of PD.
  • Ability to follow study-related commands.

You may not qualify if:

  • Musculoskeletal injury or a medical condition that would prevent safe participation in an exercise program including failure to pass the PAR-Q test.
  • The presence of any other neurological conditions.
  • Acute illness or injury that prevents participation in the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Qatar Rehabilitation Institution

Doha, 0000, Qatar

RECRUITING

Rumaila Hospital

Doha, 0000, Qatar

RECRUITING

Qatar University

Doha, 2713, Qatar

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Hanan Khalil prof Professor, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 8, 2025

Study Start

September 10, 2025

Primary Completion (Estimated)

May 10, 2026

Study Completion (Estimated)

September 10, 2026

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations