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Completed

NCT Number: NCT03833349

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

The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and depression in Parkinson's disease. It is well established that exercise improves the motor symptoms of Parkinson's disease. However, it is not clear which types of exercise are most beneficial for specific non-motor symptoms.

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Key information

Conditions

Parkinson Disease Anxiety Disorders Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Fatigue Mental Disorders Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

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About this study

This is a multi-site trial (12 patients in each site). The investigators are recruiting 24 patients who will be randomized into either a spinning class, yoga class, dance class, or no exercise intervention. Classes will be conducted twice a week for 6 weeks total at times convenient for the patients. Patients will also be asked to complete questionnaires after exercise classes to see if the exercise intervention improves measures of fatigue, anxiety, and depression - and what exercise intervention may be superior. All participants will be asked to complete questionnaires each week and will be asked to wear a "Microsoft exercise band" during the course of the study. Use of the exercise band is optional.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects diagnosed with Idiopathic Parkinson's Disease
  • Age between 18 - 75 years
  • Hoehn and Yahr stage less than or equal to 3
  • Mini-Mental State Exam (MMSE) score of over 23 at screening
  • If subjects are taking any medications for depression, fatigue, or anxiety, regimen must be stable for 8 weeks prior to baseline visit
  • Subjects willing and able to give informed consent

Exclusion criteria

  • Subjects with a diagnosis of an atypical Parkinsonism
  • Subjects unwilling or unable to obtain Health Waiver from Primary Care Provider
  • Score of 60 or more on UPDRS III at screening
  • Scores in the 'normal' range on all three study assessments: Beck Depression Index II, Fatigue Severity Scale, and Zung self-rating Anxiety Scale
  • Participation in any of the 3 physical activities more than 3 times in the past for 8 weeks prior to baseline
  • Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study

Treatment and study plan

Spinning Class

Behavioral

Spinning Class twice a week for six weeks.

Yoga Class

Behavioral

Yoga Class twice a week for six weeks.

Dance Class

Behavioral

Dance Class twice a week for six weeks.

Primary outcomes

  1. Change from baseline, if any, in subjects' Fatigue Severity Scale

    Time frame: screening through study completion, up to 18 weeks

    Subjects will complete the Fatigue Severity Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end. Each item is scored from 1(strongly disagree) to 7(strongly agree).

  2. Change from baseline, if any, in subjects' Zung self-report Anxiety Scale

    Time frame: screening through study completion, up to 18 weeks

    Subjects will complete the Zung self-report Anxiety Scale at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end. Each item is scored from 1(a little of the time) to 4(most of the time).

  3. Change from baseline, if any, in subjects' Beck Depression Inventory II scale

    Time frame: screening through study completion, up to 18 weeks

    Subjects will complete the Beck Depression Inventory II at screening and once per week during the exercise class session. Subjects also will receive a follow-up questionnaire to be completed 1 month after the class sessions end. Each item is scored from 0(Normal) to 3(Severe).

Sponsors and collaborators

Lead sponsor

Premier Health

Other

Collaborators

  • Dartmouth-Hitchcock Medical Center
  • Parkinson's Disease Foundation

Registry information

Acronym: PDExercise

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 7, 2019
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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