An interventional study of Exercise training and Sleep hygiene in Parkinson Disease, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2019-04-26.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care
Among 24 studies in Parkinson Disease by University of Alabama at Birmingham — 8 open to participants now, 9 under way, none of them phase 3. Parkinson Disease · University of Alabama at Birmingham.
Among the 24 studies in Parkinson Disease by University of Alabama at Birmingham, this one is the 20th largest by enrollment of the 20 interventional ones that give a count, is one of 3 that started in 2017, is one of 17 with no phase, and was the 12th registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
Browse Parkinson Disease studies →8 of the 24 studies in Parkinson Disease by University of Alabama at Birmingham are open now, in 1 country. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
University of Alabama at Birmingham · Sites in United States
University of Alabama at Birmingham · Sites in United States
University of Alabama at Birmingham · Sites in United States
University of Alabama at Birmingham · Sites in United States
By country, each count listing its studies:
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 1
First in 2010; this study’s year is marked. 3 started in 2017.
This study's enrollment of 4 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Median enrollment 35 across the 20 interventional studies, 117 across the 4 observational. Of the 14 that completed or were terminated, 4 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
3 of the studies in Parkinson Disease by University of Alabama at Birmingham that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04735458University of Alabama at BirminghamInvestigating Inhibitory Control Networks in Parkinson's Disease | 2027-03-31 |
| NCT07661524University of Alabama at BirminghamPassive Versus Active Music Therapy Parkinson's Disease | 2027-10-01 |
| NCT07725315University of Alabama at BirminghamInvestigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation | 2027-11-01 |
Among the 24 studies in Parkinson Disease by University of Alabama at Birmingham, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this research is to identify an intervention that will improve cognition and sleep in persons with PD.
Persons with Parkinson's disease (PD) often experience non-motor symptoms such as cognitive dysfunction and sleep problems. These symptoms can be more disabling than the motor symptoms of PD. Medications are often not effective for treating these non-motor symptoms or can have unwanted side effects. Non- medication treatments such as exercise are known to improve the motor symptoms of PD, but the effect of exercise on cognition and sleep has not been fully explored. This study investigates the impact of 16 weeks of supervised exercise, 3 times per week, compared to no-exercise over the same duration, on cognition and sleep dysfunction. Participants will be evaluated with cognitive tests and sleep studies before and after 16-weeks to determine the impact of this exercise intervention. The goal of this research is to identify an intervention that will improve cognition and sleep in persons with PD.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to the exercise training group will complete 16 weeks of exercise training. Exercise training will be performed 3x/week.
Other: Exercise training
Subjects randomized to the no-Ex group will receive a handout with tips for improving sleep hygiene. Additionally, study staff will provide the title page for a book on sleep relaxation techniques that is recommended for persons with sleeping difficulty.
Behavioral: Sleep hygiene
Exercise training will be performed 3x/week. After 2 sessions, training volume and intensity will progress over the first 4 sessions ramping up the number of sets to increase the volume. The full volume prescription will consist of: 1) 5 movements to improve strength and muscle mass (leg press, knee extension, chest press, overhead press, pull down), 3 sets each of 8-12 repetitions (\~30 total repetitions); 2) trunk exercises to improve postural stability (trunk extension and flexion); 3) 3-4 bodyweight exercises (selected from a menu) to improve power and balance (e.g. step up, squat, jump squat, lunge, side lunge, push-up, assisted pull-up, assisted dip). Bodyweight movements will be modified as necessary to match abilities.
Subjects randomized to the no-exercise group will receive a handout with tips for improving sleep. Additionally, study staff will provide the title page for a book on sleep relaxation techniques that is recommended for persons with sleeping difficulty. Dr. Amara will review the sleep tips with the subjects and make recommendations for improving current sleep habits. Subjects will be contacted by telephone every 4 weeks during the 16-week intervention period.
Executive function (Stroop inhibition, Trails B-A, Controlled oral word association)
Changes in executive function will be measured by a change in a composite executive function score calculated from the mean of z-scores for Stroop inhibition, Trails B-A, and COWA.
Time frame: changes from baseline to week 16
Sleep Efficiency
Change in sleep efficiency (the number of minutes asleep divided by the number of minutes in bed) between the baseline nocturnal polysomnography to the post-16 weeks of intervention nocturnal polysomnography
Time frame: changes from baseline and week 16
Plan to share: No — Only aggregate data will be shared.
No publications or documents are linked to this record.
Ran from May 2017 to primary completion in Nov 2018, 18 months.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 18 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham →