NCT03495193

Brief Summary

The goal of this research is to identify an intervention that will improve cognition and sleep in persons with PD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

March 27, 2018

Last Update Submit

April 25, 2019

Conditions

Parkinson Disease

Keywords

exercise

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    changes from baseline and week 16

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

Subjects randomized to the exercise training group will complete 16 weeks of exercise training. Exercise training will be performed 3x/week.

Other: Exercise training

No Exercise Group

ACTIVE COMPARATOR

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

Interventions

Exercise trainingOTHER

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.

Exercise Group
Sleep hygieneBEHAVIORAL

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.

No Exercise Group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (2)

  • 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.

    PMID: 38588457DERIVED

  • 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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The proposed study is a randomized, controlled, interventional study to investigate the impact of a novel exercise intervention on executive dysfunction (Aim 1) and objective sleep outcomes (Aim 2) in patients with PD. Thirty participants with idiopathic PD will be recruited from the University of Alabama at Birmingham (UAB) Movement Disorders Center and randomized (1:1) to one of two groups (15 per group): exercise intervention (Ex) group or no-exercise (no-Ex) control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 11, 2018

Study Start

May 18, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

April 26, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Only aggregate data will be shared.

Locations

US(1)