NCT04291027

Brief Summary

This study will investigate the impact of land based or aquatic based group exercise on the balance, walking, balance confidence, and quality of life of people with idiopathic Parkinson disease. Participants will be randomized to participate in a land based or aquatic based group exercise program 2 times per week for 12 weeks. Prior to and after participation, balance, walking, quality of life, and balance confidence will be measured by a blinded examiner.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2020

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

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

February 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

April 5, 2021

Status Verified

March 1, 2021

Enrollment Period

11 days

First QC Date

February 26, 2020

Last Update Submit

March 31, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Mini-BESTest Score

    The Mini-BESTest examines postural control. A higher scores means less balance impairment.

    Prior to intervention, after 12 week intervention

  • Change in Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS): Part III

    The Movement Disorders Society-Unified Parkinson Disease Rating Scale examines motor function for people with Parkinson disease. A higher score indicates higher motor impairment related to Parkinson disease.

    Prior to intervention, after 12 week intervention

  • Change in Gait Speed

    The 10 meter walk test will be examined at self selected and fast speeds to examine gait speed.

    Prior to intervention, after 12 week intervention

Secondary Outcomes (2)

  • Change in Parkinson Disease Questionnaire-39 (PDQ-39)

    Prior to intervention, after 12 week intervention

  • Change in Falls Efficacy Scale-International.

    Prior to intervention, after 12 week intervention

Study Arms (2)

Aquatic Group Exercise

EXPERIMENTAL
Other: Aquatic Exercise

Land Based Group Exercise

ACTIVE COMPARATOR
Other: Land Based Exercise

Interventions

Group exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training.

Land Based Group Exercise

Group exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training.

Aquatic Group Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults over the age of 18 who have been diagnosed with idiopathic Parkinson disease.
  • stable dose of levadopa medication for 30 days prior to study initiation
  • able to walk 20 feet without physical assistance
  • a referral from a physician to participate in physical therapy

You may not qualify if:

  • individuals with:
  • uncontrolled cardiovascular or pulmonary conditions
  • deep vein thrombosis in the last 6 months
  • the use of breathing tube or feeding tube
  • those with an extreme fear of exercising in the water
  • an active dermatological condition (including eczema, psoriasis, or open wound) -any other neurological condition other than Parkinson disease
  • a musculoskeletal condition that would impact their ability to participate in the exercise group
  • cognitive impairment (a score of less than 24/30 on the Mini Mental Status Examination)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ithaca College

Ithaca, New York, 14850, 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.

  • 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.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 2, 2020

Study Start

February 28, 2020

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

April 5, 2021

Record last verified: 2021-03

Locations