Parkinson's DiseaseNCT02593955
The Effects of a High Intensity Exercise Training Program in Patients With Parkinson's Disease
A study testing PD exercise and Sleep Hygiene in people with Parkinson's Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this randomized, controlled interventional study is to determine the effects of a high intensity exercise training program on objective sleep measures, daytime sleepiness, mobility, and brain health/functional connectivity in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- PD exercise and Sleep Hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to 30 Nov 2018
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with a clinical diagnosis of idiopathic Parkinson's disease based on the presence of bradykinesia and one or both of the following: rest tremor and/or rigidity
- Hoehn and Yahr stage 2 or 3
- Stable dopaminergic medication regimen for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
- Stable doses of medications known to affect sleep and medications for Parkinson's disease for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
- Age 45 or greater at time of study entry
- Asymmetric onset of PD
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- Progressive motor symptoms of PD
- Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
- MoCA score 18-26
- Ability to travel to UAB 3x/week for the 16 weeks duration of the study for exercise training sessions as well as for other study visits
- Subjects must pass a physical examination and PAR-Q to assess exercise readiness
- Age 45 or greater at time of study entry
- Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
- Normal cognition
Who cannot join
- Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
- Neuroleptic treatment at time of onset of Parkinsonism
- Active treatment with a neuroleptic at time of study entry
- History of multiple strokes with stepwise progression of Parkinsonism
- History of multiple head injuries
- Inability to walk without assistance, including a cane, wheelchair, or walker
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- Regular participation in an exercise program within the past 6 months
- Deep Brain Stimulation
- Untreated sleep apnea
- Known narcolepsy
- Participation in drug studies or the use of investigational drugs within 30 days prior to screening
- Acute illness or active, confounding medical, neurological, or musculoskeletal conditions that, at the discretion of the PI, would prevent the subject's ability to participate in the study
- Known contraindication to testing
- Active alcoholism or other drug addiction
- Pregnancy
- Exclusion criteria for PD subjects undergoing imaging studies:
- Pacemaker or other metallic object that would make MR imaging unsafe
- Claustrophobia that prevents participation in imaging portion
- Any motor, cognitive, or health disorder that in the opinion of the PI would prevent the subject from participating in the imaging portion
- Pacemaker or other metallic object that would make MR imaging unsafe
- Claustrophobia that prevents participation in imaging portion
- Any motor, cognitive, or health disorder that in the opinion of the PI would prevent the subject from participating in the imaging portion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: The Effects of a High Intensity Exercise Training Program on Sleep and Vigilance in Patients With Parkinson's Disease (The Effect of Low Frequency STN DBS on Sleep and Vigilance in PD Patients)
The purpose of this randomized, controlled interventional study is to determine the effects of a high intensity exercise training program on objective sleep measures, daytime sleepiness, mobility, and brain health/functional connectivity in patients with Parkinson's disease.
Read the detailed description
The primary outcome measure is the change in sleep efficiency (the number of minutes asleep divided by the number of minutes in bed), as measured by polysomnography. In addition, because patients with Parkinson's disease have excessive sleepiness/impaired vigilance (alertness) and impaired motor function, and because these might be expected to improve with the exercise intervention, this study will also assess vigilance and motor outcomes.
- Conditions
- Parkinson's Disease
- Being tested
- PD exercise, Sleep Hygiene
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD exerciseBehavioural
Supervised high intensity exercise 3x/week for 16 weeks
Sleep HygieneBehavioural
Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.
| Study group | Role | What they receive |
|---|---|---|
| PD exercise group | Active comparator | Supervised exercise training, 3x per week for 16 weeks Receives: Behavioral: PD exercise |
| PD sleep hygeine group | Active comparator | Tips for improved sleep hygiene, reading materials Receives: Behavioral: Sleep Hygiene |
| Healthy control | No intervention | MRI sub-study only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep efficiency measured by polysomnography
polysomnography
Measured: baseline, week 18, and week 34
Vigilance outcome measured by psychomotor vigilance task (PVT)
psychomotor vigilance task (PVT)
Measured: baseline, week 18, and week 34
Motor outcome measured by Timed up and go test (TUG)
Timed up and go test (TUG)
Measured: baseline, week 18, and week 34
Secondary outcomes (2)
Home sleep environment
comparison of sleep diaries and actigraph related to home sleep environment
Measured: baseline, week 18 and week 34
MRI Sub-study
comparison of PD and control imaging scans
Measured: baseline (both PD and control), week 18 (PD only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study start30 Nov 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
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 Alabama at BirminghamThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Amy Amara, MD, University of Alabama at Birmingham
- Investigators
- Amy Amara, MD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593955
- Sponsor's protocol ID
- F150612003
- Other IDs
- 5K23NS080912
- Status last verified
- Jan 2019
- First submitted
- 28 Oct 2015
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a High Intensity Exercise Training Program on Sleep and Vigilance in Patients With Parkinson's Disease (The Effect of Low Frequency STN DBS on Sleep and Vigilance in PD Patients)
- ClinicalTrials.gov ID
- NCT02593955
- Acronym / sponsor ID
- F150612003
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 2 Nov 2015 (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 this randomized, controlled interventional study is to determine the effects of a high intensity exercise training program on objective sleep measures, daytime sleepiness, mobility, and brain health/functional connectivity in patients with Parkinson's disease.
Detailed description
The primary outcome measure is the change in sleep efficiency (the number of minutes asleep divided by the number of minutes in bed), as measured by polysomnography. In addition, because patients with Parkinson's disease have excessive sleepiness/impaired vigilance (alertness) and impaired motor function, and because these might be expected to improve with the exercise intervention, this study will also assess vigilance and motor outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PD exercise group | Active comparator | Behavioral: PD exerciseSupervised exercise training, 3x per week for 16 weeks |
| PD sleep hygeine group | Active comparator | Behavioral: Sleep HygieneTips for improved sleep hygiene, reading materials |
| Healthy control | No intervention | –MRI sub-study only |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects with a clinical diagnosis of idiopathic Parkinson's disease based on the presence of bradykinesia and one or both of the following: rest tremor and/or rigidity
- Hoehn and Yahr stage 2 or 3
- Stable dopaminergic medication regimen for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
- Stable doses of medications known to affect sleep and medications for Parkinson's disease for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
- Age 45 or greater at time of study entry
Key exclusion criteria (22 listed)
- Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
- Neuroleptic treatment at time of onset of Parkinsonism
- Active treatment with a neuroleptic at time of study entry
- History of multiple strokes with stepwise progression of Parkinsonism
- History of multiple head injuries
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 |
|---|---|---|
| PD exerciseSupervised high intensity exercise 3x/week for 16 weeks | Behavioural | PD exercise group |
| Sleep HygieneSleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials. | Behavioural | PD sleep hygeine group |
Primary outcome
Change in sleep efficiency measured by polysomnography
Time frame: baseline, week 18, and week 34
polysomnography
Vigilance outcome measured by psychomotor vigilance task (PVT)
Time frame: baseline, week 18, and week 34
psychomotor vigilance task (PVT)
Motor outcome measured by Timed up and go test (TUG)
Time frame: baseline, week 18, and week 34
Timed up and go test (TUG)
2 secondary outcomes
Home sleep environment
Time frame: baseline, week 18 and week 34
MRI Sub-study
Time frame: baseline (both PD and control), week 18 (PD only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 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.
Amy Amara, MD, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD exercise and Sleep Hygiene in people with Parkinson's Disease, run by University of Alabama at Birmingham 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 14 inclusion and 22 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 17 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 sleep efficiency measured by polysomnography (time frame: baseline, week 18, and week 34). 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 NCT02593955, 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 17 Jan 2019.