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

NCT ID: NCT02885285

Last Updated: 2017-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-02-24

Brief Summary

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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.

Detailed Description

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The investigators are recruiting 32 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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spinning Class

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.

Group Type EXPERIMENTAL

Spinning Class

Intervention Type BEHAVIORAL

Spinning Class twice a week for six weeks.

Yoga Class

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.

Group Type EXPERIMENTAL

Yoga Class

Intervention Type BEHAVIORAL

Yoga Class twice a week for six weeks.

Dance Class

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.

Group Type EXPERIMENTAL

Dance Class

Intervention Type BEHAVIORAL

Dance Class twice a week for six weeks.

No Exercise Class

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.

Group Type ACTIVE_COMPARATOR

No Exercise Class

Intervention Type OTHER

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

Interventions

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Spinning Class

Spinning Class twice a week for six weeks.

Intervention Type BEHAVIORAL

Yoga Class

Yoga Class twice a week for six weeks.

Intervention Type BEHAVIORAL

Dance Class

Dance Class twice a week for six weeks.

Intervention Type BEHAVIORAL

No Exercise Class

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parkinson's Disease Foundation

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Feldman, DO

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Other Identifiers

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AWD00010460

Identifier Type: -

Identifier Source: org_study_id

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