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

NCT03833349 | Completed

• 1 other identifier: 06538
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; fatigue; anxiety; depression; exercise

Outcome Measures

Primary Outcomes (3)

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

  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).

  screening through study completion, up to 18 weeks

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

  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).

  screening through study completion, up to 18 weeks

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

  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).

  screening through study completion, up to 18 weeks

Study Arms (3)

Spinning Class

EXPERIMENTAL

Subjects randomly selected for the spinning group will participate in spinning classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.

Behavioral: Spinning Class

Yoga Class

EXPERIMENTAL

Subjects randomly selected for the yoga group will participate in yoga classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.

Behavioral: Yoga Class

Dance Class

EXPERIMENTAL

Subjects randomly selected for the dance group will participate in dance classes, twice a week for six weeks. Subjects will complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.

Behavioral: Dance Class

Interventions

Spinning Class BEHAVIORAL

Spinning Class twice a week for six weeks.

Spinning Class

Yoga Class BEHAVIORAL

Yoga Class twice a week for six weeks.

Yoga Class

Dance Class BEHAVIORAL

Dance Class twice a week for six weeks.

Dance Class

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Premier Health: lead
• Parkinson's Disease Foundation: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (2)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Premier Health

Dayton, Ohio, 45409, 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: 38588457 DERIVED

• 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: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Fatigue; Anxiety Disorders; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Mary Feldman, DO

  Premier Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: February 11, 2019
• Primary Completion: October 2, 2019
• Study Completion: October 2, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

US (2)