Parkinson's DiseaseNCT02267785
Exercise Targeting Cognitive Impairment in Parkinson's Disease
A study testing Skill-Based Exercise, Aerobic Exercise and Social Contact in people with Parkinson's Disease, run by University of Southern California at 1 site in United States.
Trial summary
The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on mild cognitive impairment (MCI) of the executive function (EF) subtype in Parkinson's disease (PD); we hypothesize that skill-based exercise will result in the greatest improvement in EF and… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Skill-Based Exercise, Aerobic Exercise and Social Contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willing and able to provide informed consent
- confirmed diagnosis of idiopathic PD based on the United Kingdom Brain Bank criteria
- Mild cognitive impairment (Level II criteria Movement Disorder Task Force)
- medically eligible for MRI imaging
- able to provide a written medical clearance from their primary physician to participate in exercise
- stable PD medications for 3 months
Who cannot join
- a Hoehn \& Yahr staging greater than 2.5 at screening
- severe cardiac disease (New York Heart Association classification IIIV)
- history of an abnormal stress test
- clinically significant medical or psychiatric illness
- electrically, magnetically, or mechanically activated implant (such as cardiac pacemakers or intracerebral vascular clip)
- metal in any part of the body including metal injury to the eye
Show all 18Show fewer
- past history of brain lesions (such as stroke)
- seizures or unexplained spells of loss of consciousness
- family history of epilepsy
- physical therapy within 6 months of the study
- symptomatic orthostatic hypotension at the screening visit
- orthopedic and other movement-influencing diseases such as arthritis or total hip joint replacement
- requirement for central nervous system active therapies (e.g. hypnotics, antidepressants, anxiolytics)
- moderate or severe depression or apathy using the Geriatric depression scale and Apathy scale
- taking anticholinesterase inhibitors
- taking anticholinergic medication
- PD dementia
- Colorblindness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033-4606
About this study
The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on mild cognitive impairment (MCI) of the executive function (EF) subtype in Parkinson's disease (PD); we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates.
Read the detailed description
Mild cognitive impairment (MCI), particularly of the executive function (EF) subtype, is common in Parkinson's disease (PD) and transitions to dementia, increased fall risk, and poor quality of life. EF is a set of processes that include mental flexibility and attention that are needed to learn and optimize performance of complex cognitive and motor skills. Such skills include the ability to generalize task performance under different conditions (context processing) and to perform two tasks simultaneously termed dual-task (DT) performance. Deficits in EF lead to problems in daily functioning and loss of independence and create psychosocial and economic burdens on patients and caregivers and stakeholders including health care providers. There is currently no effective treatment in PD to address EF deficits. Our animal and clinical studies in PD demonstrate that skilled exercise facilitates neuroplasticity of the basal ganglia (BG), a brain region sub-serving EF and supports the hypothesis that exercise will reverse EF deficits in PD. Furthermore, recent studies in healthy aging support that skill-based exercise that specifically promotes motor skill fitness (MSF), compared with aerobic exercise that promotes cardiovascular fitness (CF), has a greater impact on EF and related BG circuits. The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on MCI of the EF subtype in PD; we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates.
- Conditions
- Parkinson's Disease
- Being tested
- Skill-Based Exercise, Aerobic Exercise, Social Contact
- Keywords
- exercise, mild cognitive impairment, Parkinson's Disease
- Medical subject headings
- Parkinson Disease, Motor Activity, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skill-Based ExerciseOther
The skill-based exercise program is designed to improve skilled function, fine and gross- motor body coordination. The intervention will be focused on acquisition and improvement of complex movements for the whole body and include the following general categories of activities: (1) balance, (2) eye-hand coordination, (3) leg-arm coordination; 4) reaction time to moving objects/persons; (5) dynamic gait and 6) functional activity performance. The treating therapist will direct both general principles of progression and progression specific to each category.
Aerobic ExerciseOther
The aerobic cardiovascular exercise will consist of 36 1-hour sessions performed 3 times weekly over 12 weeks. Aerobic exercise will consist of cycling on a recumbent stationary bicycle. Each session will begin and end with gentle stretching. Continuous cycling will be performed for 45-50 minutes, with the first and last 5 minutes designated as warm-up and cool-down periods. The intensity of the middle 30 minutes of cycling will be increased progressively from an initial target of 50% maximum heart rate (HR) during week 1 to 75% of maximum HR by week 12. The initial intensity will be set at 50% of maximum HR. Participants will be encouraged to cycle as fast as they can, with a goal of maintaining 90 revolutions per minute (RPM) throughout the middle 30-minute period. Pedaling resistance will be kept low throughout all sessions. Measures of heart rate via heart rate monitors, blood pressure, RPM, and rate of perceived exertion will be recorded at 5-minute intervals.
Social ContactOther
The control Social Contact group will consist of an equal amount of social contact as the exercise group. Subjects will have weekly visits at the University of Southern California with the study coordinator. The goal is for 3 hours of social contact every week for a total of 36 hours over 12 weeks. Activities scheduled for the social contact visits will include: (1) support group interactions and (2) social outings such as a trip to a museum, local café for lunch or dinner; (3) book club; (4) sports event. Support group interaction can include discussions among patients and caregivers, presentations from experts in various aspects of PD. They will be instructed to continue with their usual level of activity but refrain from beginning new exercise activities during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Skill-Based Exercise | Experimental | Participants assigned to this arm will complete the Skill-Based Exercise Intervention Receives: Other: Skill-Based Exercise |
| Aerobic Exercise | Experimental | Participants assigned to this arm will complete the Aerobic Exercise Intervention Receives: Other: Aerobic Exercise |
| Social Contact Group | Experimental | Participants assigned to this arm will complete the Social Contact Intervention Receives: Other: Social Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Context Dependent Motor Learning (CDML)
All subjects from each group will undergo a finger sequence motor learning task to determine exercise effects on EF as evaluated through improvement in the transfer of a learned motor task from one contextual setting to another.
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Dual Task Performance and Functional Magnetic Resonance Imaging (fMRI)
A subset of subjects (60 representing 20 per group) will be invited to undergo fMRI studies at University of California, Los Angeles. Patients will perform a learned single finger-sequencing task (a condition of the CDML) with an additional secondary dual task (DT) component during an fMRI scan.
Measured: at Baseline, after 12 week intervention
Change in D-KEFS Verbal Fluency Test
The D-KEFS Verbal Fluency test will be used to evaluate executive function
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Tower of London Test
The Tower of London test will be used to evaluate executive function
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Wisconsin Card Sorting Test
The Wisconsin Card Sorting test will be used to evaluate executive function
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Secondary outcomes (27)
Change in Parkinson Disease Questionnaire-39 (PDQ-39)
Parkinson Disease Questionnaire-39 (PDQ-39) will be used to indicate overall quality of life and frequency with which patients experience difficulties; high scores for the PDQ-39 reflect poorer quality of life.
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Evaluation of PD Motor Symptoms with Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS is the established gold standard that is currently used for the vast majority of clinical settings and for scientific trials. This scale was developed in 1987 and is the most widely used tool in PD.
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Activity Specific Balance Confidence (ABC) Scale
Activity Specific Balance Confidence (ABC) Scale is a 16-item self-report in which patients rate their balance confidence in performing several activities; high scores indicate greater balance confidence.
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Confidence in ability to maintain an exercise program (CONF)
The CONF scale includes nine items, which assesses how sure subjects are that they would do exercise under different conditions or constraints, including when they are tired.
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Exercise Control Beliefs (BEL)
The BEL, 6-item scale was developed to assess beliefs about control over exercise behavior.
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Self-efficacy for Exercise Scale (EFFIC)
The EFFIC scale is a self-efficacy barriers to exercise measure, a 13-item instrument that focuses on self-efficacy expectations related to the ability to continue exercising in the face of barriers to exercise.
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Frontal Systems Behavior Scale (FrSBe)
The FrSBe assesses changes in behavior dysfunction and disturbances associated with frontal-subcortical damage, which is the circuitry involved with executive functioning
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Motor Skill Fitness
An individual's Motor skill fitness will be a composite score of their Physical Performance Test (PPT) and their Timed Up and Go (TUG).
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Cardiovascular Fitness
Subjects will participate in testing designed to determine their level of cardiovascular fitness by estimating maximal oxygen uptake (V02max) known as the Balke treadmill submaximal fitness test and has been optimized for use in samples of elderly adults.
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Lifetime Total Physical Activity Questionnaire (LTPAQ)
The LPAQ measures the time spent in physical activity over the lifetime of the subject
Measured: at Baseline
Change in Global Physical Activity Questionnaire (GPAQ)
The GPAQ measures the time spent in physical activity during a normal week
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Body Mass Index
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Body Fat Percentage
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Mattis Dementia Rating Scale
The Mattis Dementia Rating Scale will be used to differentiate between study subjects with mild cognitive impairment and dementia
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Geriatric Depression Scale
The Geriatric Depression Scale will be used to evaluate study subjects for depression
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Geriatric Anxiety Inventory
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Apathy Scale
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Revised Activities of Daily Living Scale
The Revised Activities of Daily Living Scale will be used to evaluate independent living skills
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in the Frontal Systems Behavior Scale (FrSBe)
The FrSBe will be used to evaluate frontal systems behavior
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Adaptive Digit Ordering Test
The Adaptive Digit Ordering Test will be used to evaluate attention and working memory
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Hooper Visual Organization Test
The Hooper Visual Organization Test will be used to evaluate visuospatial function
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Benton's Judgment of Line Orientation
The Benton's Judgment of Line Orientation test will be used to evaluate visuospatial function
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in D-KEFS Color Word Interference Test
The D-KEFS Color Word Interference Test will be used to evaluate attention, working memory and executive function
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in California Verbal Learning Test- 2nd Edition (CVLT-II)
The CVLT-II will be used to evaluate memory function
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in WMS-II Visual Reproduction Test
The WMS-II Visual Reproduction Test will be used to evaluate memory function
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in WAIS-IV Similarities Test
The WAIS-IV Similarities test will be used to evaluate language function
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Boston Naming Test
The Boston Naming Test will be used to evaluate language function
Measured: at Baseline, after 12 week intervention, and at 12 week follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Parkinson Foundation, University of California, Los Angeles
- Responsible party
- Principal investigator, Giselle Petzinger, University of Southern California
- Investigators
- Giselle M Petzinger, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267785
- Sponsor's protocol ID
- HS-14-00422
- Status last verified
- May 2019
- First submitted
- 14 Oct 2014
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Targeting Cognitive Impairment in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02267785
- Acronym / sponsor ID
- HS-14-00422
- Conditions
- Parkinson's Disease
- Keywords
- exercise, mild cognitive impairment, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Parkinson Foundation, University of California, Los Angeles
- Study start
- Oct 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Oct 2014 (estimated)
- 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 aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on mild cognitive impairment (MCI) of the executive function (EF) subtype in Parkinson's disease (PD); we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates.
Detailed description
Mild cognitive impairment (MCI), particularly of the executive function (EF) subtype, is common in Parkinson's disease (PD) and transitions to dementia, increased fall risk, and poor quality of life. EF is a set of processes that include mental flexibility and attention that are needed to learn and optimize performance of complex cognitive and motor skills. Such skills include the ability to generalize task performance under different conditions (context processing) and to perform two tasks simultaneously termed dual-task (DT) performance. Deficits in EF lead to problems in daily functioning and loss of independence and create psychosocial and economic burdens on patients and caregivers and stakeholders including health care providers. There is currently no effective treatment in PD to address EF deficits. Our animal and clinical studies in PD demonstrate that skilled exercise facilitates neuroplasticity of the basal ganglia (BG), a brain region sub-serving EF and supports the hypothesis that exercise will reverse EF deficits in PD. Furthermore, recent studies in healthy aging support that skill-based exercise that specifically promotes motor skill fitness (MSF), compared with aerobic exercise that promotes cardiovascular fitness (CF), has a greater impact on EF and related BG circuits. The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on MCI of the EF subtype in PD; we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Skill-Based Exercise | Experimental | Other: Skill-Based ExerciseParticipants assigned to this arm will complete the Skill-Based Exercise Intervention |
| Aerobic Exercise | Experimental | Other: Aerobic ExerciseParticipants assigned to this arm will complete the Aerobic Exercise Intervention |
| Social Contact Group | Experimental | Other: Social ContactParticipants assigned to this arm will complete the Social Contact Intervention |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- willing and able to provide informed consent
- confirmed diagnosis of idiopathic PD based on the United Kingdom Brain Bank criteria
- Mild cognitive impairment (Level II criteria Movement Disorder Task Force)
- medically eligible for MRI imaging
- able to provide a written medical clearance from their primary physician to participate in exercise
Key exclusion criteria (18 listed)
- a Hoehn \& Yahr staging greater than 2.5 at screening
- severe cardiac disease (New York Heart Association classification IIIV)
- history of an abnormal stress test
- clinically significant medical or psychiatric illness
- electrically, magnetically, or mechanically activated implant (such as cardiac pacemakers or intracerebral vascular clip)
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 |
|---|---|---|
| Skill-Based ExerciseThe skill-based exercise program is designed to improve skilled function, fine and gross- motor body coordination. The intervention will be focused on acquisition and improvement of complex movements for the whole body and include the following general categories of activities: (1) balance, (2) eye-hand coordination, (3) leg-arm coordination; 4) reaction time to moving objects/persons; (5) dynamic gait and 6) functional activity performance. The treating therapist will direct both general principles of progression and progression specific to each category. | Other | Skill-Based Exercise |
| Aerobic ExerciseThe aerobic cardiovascular exercise will consist of 36 1-hour sessions performed 3 times weekly over 12 weeks. Aerobic exercise will consist of cycling on a recumbent stationary bicycle. Each session will begin and end with gentle stretching. Continuous cycling will be performed for 45-50 minutes, with the first and last 5 minutes designated as warm-up and cool-down periods. The intensity of the middle 30 minutes of cycling will be increased progressively from an initial target of 50% maximum heart rate (HR) during week 1 to 75% of maximum HR by week 12. The initial intensity will be set at 50% of maximum HR. Participants will be encouraged to cycle as fast as they can, with a goal of maintaining 90 revolutions per minute (RPM) throughout the middle 30-minute period. Pedaling resistance will be kept low throughout all sessions. Measures of heart rate via heart rate monitors, blood pressure, RPM, and rate of perceived exertion will be recorded at 5-minute intervals. | Other | Aerobic Exercise |
| Social ContactThe control Social Contact group will consist of an equal amount of social contact as the exercise group. Subjects will have weekly visits at the University of Southern California with the study coordinator. The goal is for 3 hours of social contact every week for a total of 36 hours over 12 weeks. Activities scheduled for the social contact visits will include: (1) support group interactions and (2) social outings such as a trip to a museum, local café for lunch or dinner; (3) book club; (4) sports event. Support group interaction can include discussions among patients and caregivers, presentations from experts in various aspects of PD. They will be instructed to continue with their usual level of activity but refrain from beginning new exercise activities during the study period. | Other | Social Contact Group |
Primary outcome
Change in Context Dependent Motor Learning (CDML)
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
All subjects from each group will undergo a finger sequence motor learning task to determine exercise effects on EF as evaluated through improvement in the transfer of a learned motor task from one contextual setting to another.
Change in Dual Task Performance and Functional Magnetic Resonance Imaging (fMRI)
Time frame: at Baseline, after 12 week intervention
A subset of subjects (60 representing 20 per group) will be invited to undergo fMRI studies at University of California, Los Angeles. Patients will perform a learned single finger-sequencing task (a condition of the CDML) with an additional secondary dual task (DT) component during an fMRI scan.
Change in D-KEFS Verbal Fluency Test
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
The D-KEFS Verbal Fluency test will be used to evaluate executive function
Change in Tower of London Test
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
The Tower of London test will be used to evaluate executive function
Change in Wisconsin Card Sorting Test
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
The Wisconsin Card Sorting test will be used to evaluate executive function
27 secondary outcomes
Change in Parkinson Disease Questionnaire-39 (PDQ-39)
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Evaluation of PD Motor Symptoms with Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Activity Specific Balance Confidence (ABC) Scale
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Confidence in ability to maintain an exercise program (CONF)
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Exercise Control Beliefs (BEL)
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Self-efficacy for Exercise Scale (EFFIC)
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Frontal Systems Behavior Scale (FrSBe)
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Motor Skill Fitness
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Cardiovascular Fitness
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Lifetime Total Physical Activity Questionnaire (LTPAQ)
Time frame: at Baseline
Change in Global Physical Activity Questionnaire (GPAQ)
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Body Mass Index
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Body Fat Percentage
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Mattis Dementia Rating Scale
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Geriatric Depression Scale
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Geriatric Anxiety Inventory
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Apathy Scale
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Revised Activities of Daily Living Scale
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in the Frontal Systems Behavior Scale (FrSBe)
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Adaptive Digit Ordering Test
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Hooper Visual Organization Test
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Benton's Judgment of Line Orientation
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in D-KEFS Color Word Interference Test
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in California Verbal Learning Test- 2nd Edition (CVLT-II)
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in WMS-II Visual Reproduction Test
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in WAIS-IV Similarities Test
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Boston Naming Test
Time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
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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. This study is not recruiting at the moment.
Giselle M Petzinger, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skill-Based Exercise, Aerobic Exercise and Social Contact in people with Parkinson's Disease, run by University of Southern California 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 6 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 31 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Context Dependent Motor Learning (CDML) (time frame: at Baseline, after 12 week intervention, and at 12 week follow up visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267785, which also lists 2 linked publications.
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 31 May 2019.