The Effects of a High Intensity Exercise Training Program in Patients With Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Exercise in Parkinson's Disease

NCT03495193

Parkinson Disease

COMPLETED NA

The Effect of Low Frequency STN DBS on Sleep and Vigilance in Parkinson's Disease (PD) Patients

NCT01769690

Parkinson's Disease

COMPLETED NA

Mindfulness and Yoga or Resistance Exercise Training Fpr Parkinson's Patients

NCT05513534

Resistance Training Yoga

COMPLETED NA

The Impact of Three Distinct Exercise Types on Fatigue, Anxiety, and Depression in Parkinson's Disease

NCT03833349

Parkinson Disease

COMPLETED NA

Slow Wave Sleep As a Biomarker of Rehabilitation-induced Cognitive Improvement in PD

NCT04796506

Parkinson Disease

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PD exercise group

Supervised exercise training, 3x per week for 16 weeks

Group Type ACTIVE_COMPARATOR

PD exercise

Intervention Type BEHAVIORAL

Supervised high intensity exercise 3x/week for 16 weeks

PD sleep hygeine group

Tips for improved sleep hygiene, reading materials

Group Type ACTIVE_COMPARATOR

Sleep Hygiene

Intervention Type BEHAVIORAL

Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.

Healthy control

MRI sub-study only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PD exercise

Supervised high intensity exercise 3x/week for 16 weeks

Intervention Type BEHAVIORAL

Sleep Hygiene

Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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
2. Hoehn and Yahr stage 2 or 3
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.
4. 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.
5. Age 45 or greater at time of study entry
6. Asymmetric onset of PD
7. Progressive motor symptoms of PD
8. Poor sleep quality (Pittsburgh Sleep Quality Index score \>5)
9. MoCA score 18-26
10. 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
11. Subjects must pass a physical examination and PAR-Q to assess exercise readiness

1. Age 45 or greater at time of study entry
2. Poor sleep quality (Pittsburgh Sleep Quality Index score \>5)
3. Normal cognition

Exclusion Criteria

1. 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.
2. Neuroleptic treatment at time of onset of Parkinsonism
3. Active treatment with a neuroleptic at time of study entry
4. History of multiple strokes with stepwise progression of Parkinsonism
5. History of multiple head injuries
6. Inability to walk without assistance, including a cane, wheelchair, or walker
7. Regular participation in an exercise program within the past 6 months
8. Deep Brain Stimulation
9. Untreated sleep apnea
10. Known narcolepsy
11. Participation in drug studies or the use of investigational drugs within 30 days prior to screening
12. 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
13. Known contraindication to testing
14. Active alcoholism or other drug addiction
15. Pregnancy

1. Pacemaker or other metallic object that would make MR imaging unsafe
2. Claustrophobia that prevents participation in imaging portion
3. Any motor, cognitive, or health disorder that in the opinion of the PI would prevent the subject from participating in the imaging portion

1. Pacemaker or other metallic object that would make MR imaging unsafe
2. Claustrophobia that prevents participation in imaging portion
3. Any motor, cognitive, or health disorder that in the opinion of the PI would prevent the subject from participating in the imaging portion

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes