Parkinson Disease (PD)LifePDNCT06603012
Behavioral Intervention for Lifestyle Physical Activity in Parkinson's Disease
A study testing GET Up PD and Stretching and Flexibility in people with Parkinson Disease (PD), run by University of Illinois Chicago at 1 site in United States.
Trial summary
The investigators propose a Stage-I randomized controlled trial (RCT) of a remotely-delivered, 16-week social-cognitive theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding increases in device-measured physical activity and improvements in cognitive… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- GET Up PD and Stretching and Flexibility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Aug 2027
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of PD
- Internet and email access
- willingness to complete the cognitive assessments and questionnaires, wear the accelerometer, and undergo randomization
- insufficient physical activity (i.e., not meeting current physical activity guidelines) based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire
- self-reported ability to ambulate without assistance
- age of 50+ years
- English as a primary language
- asymptomatic (i.e., one or fewer affirmatives on the Physical Activity Readiness Questionnaire [PAR-Q]) or physician approval for undertaking exercise training for those with 2 or more affirmatives on the PAR-Q
Who cannot join
- above inclusion criteria not met
- moderate or high risk of contraindications for possible injury or death when undertaking strenuous or maximal exercise using the PAR-Q
- severe cognitive impairment that might preclude compliance with the conditions based on a modified Telephone Interview for Cognitive Status (TICS-M) score of less than 18
- normal cognitive impairment based on the Montreal Cognitive Assessment (MoCA) score of 26 or more for avoiding ceiling effects involving change in cognitive function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
Robert Motl, PhD, 312-413-0319, robmotl@uic.edu
About this study
The investigators propose a Stage-I randomized controlled trial (RCT) of a remotely-delivered, 16-week social-cognitive theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding increases in device-measured physical activity and improvements in cognitive function, symptoms, and quality of life (QOL), and social-cognitive theory (SCT) outcomes among physically inactive persons with Parkinson's disease (PD). Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant\'s home/community and supported by Zoom-based chats guided by SCT via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. The investigators hypothesize that the home-based exercise intervention will yield improvements in cognitive, symptomatic, and QOL outcomes.
Read the detailed description
Parkinson's disease (PD) is a neurodegenerative disorder of the dopamine-producing nerve cells in the basal ganglia, and age is a primary risk factor for PD. Cognitive impairment is prevalent, disabling, and poorly managed among the 1 million adults living with PD in the United States. Indeed, cognitive impairment begins early in PD, and dementia develops in 80% of persons with PD. Cognitive impairment is further associated with worse fatigue, depression, anxiety, pain, and quality of life (QOL) in PD. Those observations underscore the importance of identifying efficacious approaches for managing cognitive impairment and its consequences, and promoting additional health benefits among those with PD. To date, researchers have examined the benefits of supervised, structured exercise training for managing outcomes of PD, but this approach has clear barriers associated with travel, transportation, and participation (i.e., loss of driving ability, social isolation, and lack of community integration) that are common in PD. The investigators believe that there is merit in the promotion of physical activity for managing cognitive dysfunction and other symptom and QOL outcomes in PD. The investigators offer a novel and innovative approach for promotion of physical activity in PD based on their extensive experiences from Phase I, II, and III randomized controlled trials (RCTs). Those RCTs indicate that the remotely-delivered, social-cognitive theory-based behavioral intervention has successfully increased self-reported and device-measured physical activity in persons with multiple sclerosis (MS). This approach has further resulted in improvements in cognition and walking outcomes, symptoms of fatigue, depression, anxiety, and pain, and QOL among persons with MS. The investigators leverage their experiences and preliminary results in MS, and propose a Stage-I RCT that examines the feasibility and efficacy of a remotely-delivered, theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding immediate improvements in device-measured physical activity (primary outcome) among persons with PD who are physically inactive. The investigators further examine the efficacy of this behavioral intervention for improvements in cognitive function, symptoms, and QOL (secondary outcomes). The proposed study, if successful, will provide experiences and pilot data necessary for the design of a subsequent Stage-II RCT that examines the efficacy of the behavioral intervention for immediate and sustained improvements of outcomes in an appropriately-powered and clearly-demarcated sample of adults with PD (i.e., those 50+ years of age who are prescreened for cognitive impairment). This line of research may yield "real-world" guidelines for physical activity that can be implemented for the treatment of cognitive dysfunction and other outcomes in PD. Such an opportunity for rehabilitation of cognitive function using an approach with broad reach and scalability is paramount considering the prevalent, disabling, and poorly managed nature of cognitive impairment in PD and limited efficacious resources for its treatment.
- Conditions
- Parkinson Disease (PD)
- Being tested
- GET Up PD, Stretching and Flexibility
- Keywords
- Parkinson disease, Parkinsonian disorders, Movement disorders, Basal ganglia diseases, Brain diseases, Nervous system diseases, Central nervous system diseases, Neurodegenerative diseases, Cognition, Walking, Exercise, Physical Activity
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Movement Disorders, Basal Ganglia Diseases, Brain Diseases, Nervous System Diseases, Central Nervous System Diseases, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GET Up PDBehavioural
- The exercise training prescription involves performing 3 days per week and include (a) aerobic exercise: 30+ minutes of moderate-intensity walking (≥100 steps/min) monitored by a waist-worn pedometer, and (b) resistance training: 1-3 sets, 8-12 repetitions of 5-10 exercises targeting lower and upper body, and core muscle groups using elastic bands.
- Other components of the GET Up PD program include appropriate exercise equipment (pedometer, resistance bands), one-on-one coaching sessions via Zoom, action-planning via calendars, logbooks for self-monitoring, and SCT-based newsletters.
Stretching and FlexibilityBehavioural
- The training will involve the same frequency, duration, timeline, behavior change content, and interactions with behavioral coach as the GET Up PD program, and account for activity, social-contact, and attention.
- Other components of the Stretching and Flexibility program include appropriate exercise equipment (yoga mat), one-on-one coaching sessions via Zoom, calendars, logbooks and newsletters similar to the GET Up PD program.
| Study group | Role | What they receive |
|---|---|---|
| GET Up PD | Experimental | Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training Receives: Behavioral: GET Up PD |
| Stretching and Flexibility | Active comparator | Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training Receives: Behavioral: Stretching and Flexibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
ActiGraph Gt3X+ accelerometer; minutes spent in light physical activity per day
Measured: Changes in time spent in light physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Physical Activity
ActiGraph Gt3X+ accelerometer; minutes spent in moderate-to-vigorous physical activity per day
Measured: Changes in time spent in moderate-to-vigorous physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Secondary outcomes (7)
Cognitive Function
SCales for Outcomes in PArkinson's disease - COGnition (SCOPA-Cog); scores range between 0-43, higher scores indicate better cognitive function
Measured: Changes in SCOPA-Cog Baseline (pre-intervention) to after 16 weeks (post-intervention)
Fatigue Severity
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity
Measured: Changes in fatigue severity scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Depressive Symptoms
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms
Measured: Changes in depressive symptoms scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Fatigue Impact
Modified Fatigue Impact Scale (MFIS); scores range between 0 (min) and 84 (max), higher scores reflect a greater impact of fatigue on daily life
Measured: Changes in fatigue impact scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Anxiety
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms
Measured: Changes in anxiety scores from Baseline (pre-intervention) to after 16 weeks (post-intervention
Perceived Pain
Short-form McGill Pain Questionnaire (SF-MPQ); scores range between 0 and 45, higher scores indicate more perceived pain
Measured: Changes in perceived pain from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Health-related Quality of Life
Short Form Health Status Survey (SF-36); scores range between 0 (min) and 100 (max), higher scores indicate better physical and mental aspects of quality of life
Measured: Changes in SF-36 scores from Baseline (pre-intervention), after 16 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Robert W Motl, University of Illinois Chicago
- Investigators
- Robert Motl, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603012
- Sponsor's protocol ID
- STUDY2024-1038
- Other IDs
- P30AG022849
- Acronym
- LifePD
- Status last verified
- Jun 2026
- First submitted
- 16 Sep 2024
- Last updated
- 4 Jun 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention for Lifestyle Physical Activity in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06603012
- Acronym / sponsor ID
- LifePD / STUDY2024-1038
- Conditions
- Parkinson Disease (PD)
- Keywords
- Parkinson disease, Parkinsonian disorders, Movement disorders, Basal ganglia diseases, Brain diseases, Nervous system diseases, Central nervous system diseases, Neurodegenerative diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
The investigators propose a Stage-I randomized controlled trial (RCT) of a remotely-delivered, 16-week social-cognitive theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding increases in device-measured physical activity and improvements in cognitive function, symptoms, and quality of life (QOL), and social-cognitive theory (SCT) outcomes among physically inactive persons with Parkinson's disease (PD). Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant\'s home/community and supported by Zoom-based chats guided by SCT via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. The investigators hypothesize that the home-based exercise intervention will yield improvements in cognitive, symptomatic, and QOL outcomes.
Detailed description
Parkinson's disease (PD) is a neurodegenerative disorder of the dopamine-producing nerve cells in the basal ganglia, and age is a primary risk factor for PD. Cognitive impairment is prevalent, disabling, and poorly managed among the 1 million adults living with PD in the United States. Indeed, cognitive impairment begins early in PD, and dementia develops in 80% of persons with PD. Cognitive impairment is further associated with worse fatigue, depression, anxiety, pain, and quality of life (QOL) in PD. Those observations underscore the importance of identifying efficacious approaches for managing cognitive impairment and its consequences, and promoting additional health benefits among those with PD. To date, researchers have examined the benefits of supervised, structured exercise training for managing outcomes of PD, but this approach has clear barriers associated with travel, transportation, and participation (i.e., loss of driving ability, social isolation, and lack of community integration) that are common in PD. The investigators believe that there is merit in the promotion of physical activity for managing cognitive dysfunction and other symptom and QOL outcomes in PD. The investigators offer a novel and innovative approach for promotion of physical activity in PD based on their extensive experiences from Phase I, II, and III randomized controlled trials (RCTs). Those RCTs indicate that the remotely-delivered, social-cognitive theory-based behavioral intervention has successfully increased self-reported and device-measured physical activity in persons with multiple sclerosis (MS). This approach has further resulted in improvements in cognition and walking outcomes, symptoms of fatigue, depression, anxiety, and pain, and QOL among persons with MS. The investigators leverage their experiences and preliminary results in MS, and propose a Stage-I RCT that examines the feasibility and efficacy of a remotely-delivered, theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding immediate improvements in device-measured physical activity (primary outcome) among persons with PD who are physically inactive. The investigators further examine the efficacy of this behavioral intervention for improvements in cognitive function, symptoms, and QOL (secondary outcomes). The proposed study, if successful, will provide experiences and pilot data necessary for the design of a subsequent Stage-II RCT that examines the efficacy of the behavioral intervention for immediate and sustained improvements of outcomes in an appropriately-powered and clearly-demarcated sample of adults with PD (i.e., those 50+ years of age who are prescreened for cognitive impairment). This line of research may yield "real-world" guidelines for physical activity that can be implemented for the treatment of cognitive dysfunction and other outcomes in PD. Such an opportunity for rehabilitation of cognitive function using an approach with broad reach and scalability is paramount considering the prevalent, disabling, and poorly managed nature of cognitive impairment in PD and limited efficacious resources for its treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GET Up PD | Experimental | Behavioral: GET Up PDRemotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training |
| Stretching and Flexibility | Active comparator | Behavioral: Stretching and FlexibilityRemotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- confirmed diagnosis of PD
- Internet and email access
- willingness to complete the cognitive assessments and questionnaires, wear the accelerometer, and undergo randomization
- insufficient physical activity (i.e., not meeting current physical activity guidelines) based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire
- self-reported ability to ambulate without assistance
Key exclusion criteria (4 listed)
- above inclusion criteria not met
- moderate or high risk of contraindications for possible injury or death when undertaking strenuous or maximal exercise using the PAR-Q
- severe cognitive impairment that might preclude compliance with the conditions based on a modified Telephone Interview for Cognitive Status (TICS-M) score of less than 18
- normal cognitive impairment based on the Montreal Cognitive Assessment (MoCA) score of 26 or more for avoiding ceiling effects involving change in cognitive function
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 |
|---|---|---|
| GET Up PD* The exercise training prescription involves performing 3 days per week and include (a) aerobic exercise: 30+ minutes of moderate-intensity walking (≥100 steps/min) monitored by a waist-worn pedometer, and (b) resistance training: 1-3 sets, 8-12 repetitions of 5-10 exercises targeting lower and upper body, and core muscle groups using elastic bands. * Other components of the GET Up PD program include appropriate exercise equipment (pedometer, resistance bands), one-on-one coaching sessions via Zoom, action-planning via calendars, logbooks for self-monitoring, and SCT-based newsletters. | Behavioural | GET Up PD |
| Stretching and Flexibility* The training will involve the same frequency, duration, timeline, behavior change content, and interactions with behavioral coach as the GET Up PD program, and account for activity, social-contact, and attention. * Other components of the Stretching and Flexibility program include appropriate exercise equipment (yoga mat), one-on-one coaching sessions via Zoom, calendars, logbooks and newsletters similar to the GET Up PD program. | Behavioural | Stretching and Flexibility |
Primary outcome
Physical Activity
Time frame: Changes in time spent in light physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)
ActiGraph Gt3X+ accelerometer; minutes spent in light physical activity per day
Physical Activity
Time frame: Changes in time spent in moderate-to-vigorous physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)
ActiGraph Gt3X+ accelerometer; minutes spent in moderate-to-vigorous physical activity per day
7 secondary outcomes
Cognitive Function
Time frame: Changes in SCOPA-Cog Baseline (pre-intervention) to after 16 weeks (post-intervention)
Fatigue Severity
Time frame: Changes in fatigue severity scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Depressive Symptoms
Time frame: Changes in depressive symptoms scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Fatigue Impact
Time frame: Changes in fatigue impact scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Anxiety
Time frame: Changes in anxiety scores from Baseline (pre-intervention) to after 16 weeks (post-intervention
Perceived Pain
Time frame: Changes in perceived pain from Baseline (pre-intervention) to after 16 weeks (post-intervention)
Health-related Quality of Life
Time frame: Changes in SF-36 scores from Baseline (pre-intervention), after 16 weeks (post-intervention)
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 4 Jun 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.
Robert Motl, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GET Up PD and Stretching and Flexibility in people with Parkinson Disease (PD), run by University of Illinois Chicago at 1 site in United States.
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 8 inclusion and 4 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 4 Jun 2026. 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 United States. 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?
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 Brenda Jeng, PhD (312-996-6615, enrl@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: Changes in time spent in light physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)). 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 4 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.