Impact of Exercise in Parkinson's Disease
25 april 2019 uppdaterad av: Amy Amara, MD, University of Alabama at Birmingham
Impact of a Novel Exercise Intervention on Executive Function and Sleep in Patients With Parkinson's Disease
The goal of this research is to identify an intervention that will improve cognition and sleep in persons with PD.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
4
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- University of Alabama at Birmingham
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
45 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- a clinical diagnosis of idiopathic PD, based on the presence of bradykinesia as well as rest tremor and/or rigidity;
- Hoehn and Yahr stage 2-3;
- age ≥ 45;
- on stable medications for at least 4 weeks prior to study entry;
- Participants must have Montreal Cognitive Assessment (MoCA) score ≥ 18;
- No contraindications to an exercise program, based on the Physical Activity Readiness Questionnaire (PAR-Q), resting physical examination, and 12-lead electrocardiogram.
Exclusion Criteria:
- features suggestive of atypical Parkinsonism (cerebellar signs, supranuclear gaze palsy, prominent autonomic failure, or prominent upper motor neuron signs);
- secondary Parkinsonism (multiple strokes with stepwise progression of Parkinsonism, neuroleptic treatment at time of diagnosis, or multiple head injuries);
- inability to walk without a cane or walker;
- regular participation in an exercise program in the past 6 months;
- presence of deep brain stimulator; and
- untreated sleep apnea.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Exercise Group
Subjects randomized to the exercise training group will complete 16 weeks of exercise training.
Exercise training will be performed 3x/week.
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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.
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Aktiv komparator: No Exercise Group
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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Executive function (Stroop inhibition, Trails B-A, Controlled oral word association)
Tidsram: changes from baseline to week 16
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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.
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changes from baseline to week 16
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Sleep Efficiency
Tidsram: changes from baseline and week 16
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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
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changes from baseline and week 16
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 maj 2017
Primärt slutförande (Faktisk)
30 november 2018
Avslutad studie (Faktisk)
30 november 2018
Studieregistreringsdatum
Först inskickad
27 mars 2018
Först inskickad som uppfyllde QC-kriterierna
4 april 2018
Första postat (Faktisk)
11 april 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 april 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 april 2019
Senast verifierad
1 april 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB-170324012
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
IPD-planbeskrivning
Only aggregate data will be shared.
Läkemedels- och apparatinformation, studiedokument
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Nej
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