Parkinson's DiseasePD&ExerciseNCT02885285
The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
A study testing Spinning Class, Yoga Class and Dance Class in people with Parkinson's Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and depression in Parkinson's disease. It is well established that exercise improves the motor symptoms of Parkinson's disease. However, it is not clear which types of exercise are most beneficial for specific non-motor symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Spinning Class, Yoga Class and Dance Class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 24 Feb 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with Idiopathic Parkinson's Disease
- Age between 18 - 75 years
- Hoehn and Yahr stage less than or equal to 3
- Mini-Mental State Exam (MMSE) score of over 23 at screening
- If subjects are taking any medications for depression, fatigue, or anxiety, regimen must be stable for 8 weeks prior to baseline visit
- Subjects willing and able to give informed consent
Who cannot join
- Subjects with a diagnosis of an atypical Parkinsonism
- Subjects unwilling or unable to obtain Health Waiver from Primary Care Provider
- Score of 60 or more on UPDRS III at screening
- Scores in the 'normal' range on all three study assessments: Beck Depression Index II, Fatigue Severity Scale, and Zung self-rating Anxiety Scale
- Participation in any of the 3 physical activities more than 3 times in the past for 8 weeks prior to baseline
- Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and depression in Parkinson's disease. It is well established that exercise improves the motor symptoms of Parkinson's disease. However, it is not clear which types of exercise are most beneficial for specific non-motor symptoms.
Read the detailed description
The investigators are recruiting 32 patients who will be randomized into either a spinning class, yoga class, dance class, or no exercise intervention. Classes will be conducted twice a week for 6 weeks total at times convenient for the patients. Patients will also be asked to complete questionnaires after exercise classes to see if the exercise intervention improves measures of fatigue, anxiety, and depression - and what exercise intervention may be superior.
- Conditions
- Parkinson's Disease
- Being tested
- Spinning Class, Yoga Class, Dance Class, No Exercise Class
- Keywords
- Parkinson's disease, fatigue, anxiety, depression, exercise
- Medical subject headings
- Parkinson Disease, Fatigue, Anxiety Disorders, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinning ClassBehavioural
Spinning Class twice a week for six weeks.
Yoga ClassBehavioural
Yoga Class twice a week for six weeks.
Dance ClassBehavioural
Dance Class twice a week for six weeks.
No Exercise ClassOther
No exercise class. Subject will continue regular activities for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Spinning Class | Experimental | Subjects randomly selected for the spinning group will participate in spinning classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up. Receives: Behavioral: Spinning Class |
| Yoga Class | Experimental | Subjects randomly selected for the yoga group will participate in yoga classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up. Receives: Behavioral: Yoga Class |
| Dance Class | Experimental | Subjects randomly selected for the dance group will participate in dance classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up. Receives: Behavioral: Dance Class |
| No Exercise Class | Active comparator | Subjects randomly selected for the no class group will not participate in the study exercise classes. Subjects will still complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up. Receives: Other: No Exercise Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline, if any, in subjects' Fatigue Severity Scale
Subjects will complete the Fatigue Severity Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Measured: screening through study completion, up to 18 weeks
Change from baseline, if any, in subjects' Zung self-report Anxiety Scale
Subjects will complete the Zung self-report Anxiety Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Measured: screening through study completion, up to 18 weeks
Change from baseline, if any, in subjects' Beck Depression Inventory II scale
Subjects will complete the Beck Depression Inventory II at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Measured: screening through study completion, up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion24 Feb 2017
- Study completion24 Feb 2017
Why it stopped: Recruitment goal not met
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.
- 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
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Disease Foundation
- Responsible party
- Sponsor
- Investigators
- Mary Feldman, DO, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885285
- Sponsor's protocol ID
- AWD00010460
- Acronym
- PD&Exercise
- Status last verified
- Jul 2017
- First submitted
- 24 Aug 2016
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02885285
- Acronym / sponsor ID
- PD&Exercise / AWD00010460
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, fatigue, anxiety, depression, exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment goal not met
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Parkinson's Disease Foundation
- Study start
- Aug 2016
- Primary completion
- 24 Feb 2017 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 31 Aug 2016 (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 purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and depression in Parkinson's disease. It is well established that exercise improves the motor symptoms of Parkinson's disease. However, it is not clear which types of exercise are most beneficial for specific non-motor symptoms.
Detailed description
The investigators are recruiting 32 patients who will be randomized into either a spinning class, yoga class, dance class, or no exercise intervention. Classes will be conducted twice a week for 6 weeks total at times convenient for the patients. Patients will also be asked to complete questionnaires after exercise classes to see if the exercise intervention improves measures of fatigue, anxiety, and depression - and what exercise intervention may be superior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Spinning Class | Experimental | Behavioral: Spinning ClassSubjects randomly selected for the spinning group will participate in spinning classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up. |
| Yoga Class | Experimental | Behavioral: Yoga ClassSubjects randomly selected for the yoga group will participate in yoga classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up. |
| Dance Class | Experimental | Behavioral: Dance ClassSubjects randomly selected for the dance group will participate in dance classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up. |
| No Exercise Class | Active comparator | Other: No Exercise ClassSubjects randomly selected for the no class group will not participate in the study exercise classes. Subjects will still complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects diagnosed with Idiopathic Parkinson's Disease
- Age between 18 - 75 years
- Hoehn and Yahr stage less than or equal to 3
- Mini-Mental State Exam (MMSE) score of over 23 at screening
- If subjects are taking any medications for depression, fatigue, or anxiety, regimen must be stable for 8 weeks prior to baseline visit
Key exclusion criteria (6 listed)
- Subjects with a diagnosis of an atypical Parkinsonism
- Subjects unwilling or unable to obtain Health Waiver from Primary Care Provider
- Score of 60 or more on UPDRS III at screening
- Scores in the 'normal' range on all three study assessments: Beck Depression Index II, Fatigue Severity Scale, and Zung self-rating Anxiety Scale
- Participation in any of the 3 physical activities more than 3 times in the past for 8 weeks prior to baseline
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 |
|---|---|---|
| Spinning ClassSpinning Class twice a week for six weeks. | Behavioural | Spinning Class |
| Yoga ClassYoga Class twice a week for six weeks. | Behavioural | Yoga Class |
| Dance ClassDance Class twice a week for six weeks. | Behavioural | Dance Class |
| No Exercise ClassNo exercise class. Subject will continue regular activities for six weeks. | Other | No Exercise Class |
Primary outcome
Change from baseline, if any, in subjects' Fatigue Severity Scale
Time frame: screening through study completion, up to 18 weeks
Subjects will complete the Fatigue Severity Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Change from baseline, if any, in subjects' Zung self-report Anxiety Scale
Time frame: screening through study completion, up to 18 weeks
Subjects will complete the Zung self-report Anxiety Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Change from baseline, if any, in subjects' Beck Depression Inventory II scale
Time frame: screening through study completion, up to 18 weeks
Subjects will complete the Beck Depression Inventory II at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end.
Results and safety
The study was stopped early (reason given: Recruitment goal not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Mary Feldman, DO principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinning Class, Yoga Class and Dance Class in people with Parkinson's Disease, run by Dartmouth-Hitchcock Medical Center 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 6 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: stopped early, as of the sponsor's last update on 26 Jul 2017. 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?
The study was stopped early (reason given: Recruitment goal not met). 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 from baseline, if any, in subjects' Fatigue Severity Scale (time frame: screening through study completion, up to 18 weeks). The study lists 3 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 NCT02885285, 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 26 Jul 2017.