Parkinson's DiseaseNCT02898740
Telephone-linked Home-based Exercise Training in PD
A study testing Structural exercise and Health education in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Structural exercise and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
- At least 2 of 3 cardial signs of PD
- Response to dopaminergic medication
- Depression
Who cannot join
- Angina pectoris
- History of myocardial infarction within 6 months
- History of ventricular dysrhythmia requiring current therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease.
Read the detailed description
Background/Rationale:
Nonmotor symptoms in Parkinson's disease (PD) are thought to be present from the early stages of disease and are often more disabling and resistant to treatment than motor symptoms. One of the most important and serious of these symptoms is depression. However, there is no consensus on best pharmacological treatment for depression in PD as efficacy is lacking and there is much concern about polypharmacy and safety of various antidepressant medications. Therefore, it is essential that the investigators characterize the effects of nonpharmacological interventions on depression in PD. A number of studies have shown significant benefits of exercise in reducing depressive symptoms. Emerging studies indicate similar benefits of exercise in the form of resistance training in limiting depression in older adults as well as in those with PD.
Objective:
The investigators hypothesize that a home-based exercise intervention will reduce depression in Veterans with depression in PD.
Methods:
The proposed study is a randomized, controlled trial of a structured exercise intervention, evaluating effects on depression. Community-dwelling Veterans with depression in PD will be randomized to the exercise intervention or a health education control intervention. Participants will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, response to dopaminergic medication, and depression. The interventions will last 6 months.
- Conditions
- Parkinson's Disease
- Being tested
- Structural exercise, Health education
- Keywords
- Parkinson's disease, exercise therapy, quality of life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural exerciseBehavioural
Exercise instruction and encouragement
Health educationBehavioural
Provision of general information about a variety of health topics
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Structured exercise Receives: Behavioral: Structural exercise |
| Health Education | Active comparator | Health education Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months
The HAM-D is the most widely used and accepted measure for evaluating depression severity. The HAM-D scores range from a minimum of 0 to a maximum of 50. Higher scores indicate more severe depression. Change = (6 month score) - (baseline score).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start1 Feb 2017
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David W Sparrow, DSc, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898740
- Sponsor's protocol ID
- E2362-P
- Status last verified
- Oct 2019
- First submitted
- 8 Sep 2016
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-linked Home-based Exercise Training in PD
- ClinicalTrials.gov ID
- NCT02898740
- Acronym / sponsor ID
- E2362-P
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, exercise therapy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Posted 21 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is investigating whether a home-based exercise program will reduce depression in patients with Parkinson's disease.
Detailed description
Background/Rationale:
Nonmotor symptoms in Parkinson's disease (PD) are thought to be present from the early stages of disease and are often more disabling and resistant to treatment than motor symptoms. One of the most important and serious of these symptoms is depression. However, there is no consensus on best pharmacological treatment for depression in PD as efficacy is lacking and there is much concern about polypharmacy and safety of various antidepressant medications. Therefore, it is essential that the investigators characterize the effects of nonpharmacological interventions on depression in PD. A number of studies have shown significant benefits of exercise in reducing depressive symptoms. Emerging studies indicate similar benefits of exercise in the form of resistance training in limiting depression in older adults as well as in those with PD.
Objective:
The investigators hypothesize that a home-based exercise intervention will reduce depression in Veterans with depression in PD.
Methods:
The proposed study is a randomized, controlled trial of a structured exercise intervention, evaluating effects on depression. Community-dwelling Veterans with depression in PD will be randomized to the exercise intervention or a health education control intervention. Participants will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, response to dopaminergic medication, and depression. The interventions will last 6 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Structural exerciseStructured exercise |
| Health Education | Active comparator | Behavioral: Health educationHealth education |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
- At least 2 of 3 cardial signs of PD
- Response to dopaminergic medication
- Depression
Key exclusion criteria (3 listed)
- Angina pectoris
- History of myocardial infarction within 6 months
- History of ventricular dysrhythmia requiring current therapy
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 |
|---|---|---|
| Structural exerciseExercise instruction and encouragement | Behavioural | Exercise |
| Health educationProvision of general information about a variety of health topics | Behavioural | Health Education |
Primary outcome
Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months
Time frame: Baseline and 6 months
The HAM-D is the most widely used and accepted measure for evaluating depression severity. The HAM-D scores range from a minimum of 0 to a maximum of 50. Higher scores indicate more severe depression. Change = (6 month score) - (baseline score).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
David W Sparrow, DSc principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structural exercise and Health education in people with Parkinson's Disease, run by VA Office of Research and Development 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 21 Nov 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?
Yes. Results are posted in the registry (first posted 21 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months (time frame: Baseline and 6 months). 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 21 Nov 2019.