NCT02885285

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2017

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

August 24, 2016

Last Update Submit

July 25, 2017

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasefatigueanxietydepressionexercise

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.

    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.

    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.

    screening through study completion, up to 18 weeks

Study Arms (4)

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

No Exercise Class

ACTIVE COMPARATOR

Subjects randomly selected for the no class group will not participate in the study exercise classes. Subjects will still complete questionnaires at screening, each week during the class sessions, and for 1 month follow-up.

Other: No Exercise Class

Interventions

Spinning ClassBEHAVIORAL

Spinning Class twice a week for six weeks.

Spinning Class
Yoga ClassBEHAVIORAL

Yoga Class twice a week for six weeks.

Yoga Class
Dance ClassBEHAVIORAL

Dance Class twice a week for six weeks.

Dance Class
No Exercise ClassOTHER

No exercise class. Subject will continue regular activities for six weeks.

No Exercise Class

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, 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 DiseaseFatigueAnxiety DisordersDepressionMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Mary Feldman, DO

    Dartmouth-Hitchcock Medical Center

    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

August 24, 2016

First Posted

August 31, 2016

Study Start

August 1, 2016

Primary Completion

February 24, 2017

Study Completion

February 24, 2017

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

US(1)