Study of Axial Mobility Exercises in Parkinson Disease | NCT00004760

Studies
Study of Axial Mobility Exercises in Parkinson Disease

NCT00004760

Sponsor

Duke University

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

Exercise

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DUMC-722955R2

Status Module

Record Verification Date

Apr 1998

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1995

Primary Completion Date

Not provided

Completion Date

Dec 1997

First Submitted Date

Feb 24, 2000

First Submission Date that Met QC Criteria

Feb 24, 2000

First Posted Date

Feb 25, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

Brief Summary

OBJECTIVES:

I. Compare the benefit of exercise versus usual care (no exercise) on impairments and functional limitations in patients with Parkinson disease.

Detailed Description

PROTOCOL OUTLINE: This is a randomized study. Patients assigned to the Axial Mobility Exercise Program participate 3 times a week for 10 weeks. The program consists of individualized exercises specifically directed toward restoration of axial mobility in the context of functional tasks.

Patients assigned to the control group receive standard care (no exercise).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Behavioral

Eligibility Module

Eligibility Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Stage 2 or 3 Parkinson disease (Hoehn/Yahr scale) Able to ambulate independently Able to function independently in home Moderate rigidity No moderate or severe tremor --Prior/Concurrent Therapy-- Concurrent stable pharmacologic regimen required --Patient Characteristics-- Cardiovascular: No unstable angina Other: No psychiatric or medical contraindication to exercise, e.g., dementia, hip fracture; no other neurologic disorder, e.g., stroke, multiple sclerosis; resides within 30 miles of Duke University

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Margaret Schenkman	Duke University	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
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. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
36602886

ID	Term
D010300	Parkinson Disease
D009461	Neurologic Manifestations
D001523	Mental Disorders
D035583	Rare Diseases

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena