Exercise for Stable Myasthenia Gravis | NCT01047761

Studies
Exercise for Stable Myasthenia Gravis

NCT01047761

Sponsor

Baltimore VA Medical Center

Status

Unknown status

Last Update Posted

Nov 1, 2016Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Myasthenia Gravis

Interventions

Exercise

Countries

United States

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

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jan 12, 2010

First Submission Date that Met QC Criteria

Jan 12, 2010

First Posted Date

Jan 13, 2010Estimated

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

Oct 28, 2016

Last Update Posted Date

Nov 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Charlene Elaine Hafer-Macko, Myasthenia Gravis and Exercise, Baltimore VA Medical CenterPrincipal Investigator

Lead Sponsor

Baltimore VA Medical CenterFED

Collaborators

Name	Class
University of Maryland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Generalized fatigue in myasthenia gravis results in physical deconditioning that reduces fitness and increases risk of obesity, hypertension, elevated cholesterol and type 2 diabetes. This study will examine how active and fit are 30 individuals with chronic, generalized myasthenic subjects. This study will also determine whether a 3 month home exercise program with aerobic, resistive, and pulmonary training can improve physical activity, strength, fitness, lung function and reduce cardiovascular disease risk.

Detailed Description

Generalized fatigue in myasthenia gravis results in a sedentary lifestyle and profound physical deconditioning, leading to reduced fitness and increased risk of obesity, hypertension, dyslipidemia, and type 2 diabetes. This study will characterize the activity and fitness levels and cardiovascular disease risk profile in 30 chronic, generalized myasthenic subjects. Hypotheses are that a) subjects with myasthenia gravis are physically inactive with reduced fitness level and high incidence of obesity and poor cardiovascular disease risk profile, and b) a 3 month multi-modal home exercise program that includes aerobic, resistive, and pulmonary training components will improve physical activity, strength, fitness, dyspnea, body composition and reduce cardiovascular disease risk. Specific aims are to a) define the baseline physical activity and fitness levels and prevalence of insulin resistance and dyslipidemia in stable sedentary myasthenic subjects, b) determine whether a 3 month moderate intensity home exercise program is safe and feasible in deconditioned, stable myasthenic subjects and c) whether a 3 month comprehensive home exercise program can enhance fitness, strength, and lung function to improve physical activity and reduce cardiovascular disease risk.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exercise	Experimental	Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening.	Other: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Other	3 month exercise intervention, three days a week Progressive in duration - up to 1 hour daily; Progressive in intensity Multi-modal exercise program includes a) aerobic - walking, b) resistive training with therabands and core exercises, and c) breathing exercises

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve		Baseline and 3 months

Secondary Outcomes

Measure	Description	Time Frame
Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)		Baseline and 3 month
Muscle strength by dynamometer		Baseline and 3 month
Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stable generalized myasthenia gravis
adults age 18-70

Exclusion Criteria:

already performing regular exercise
unstable angina
recent (<3 month) myocardial infarction, stroke, hospitalization for major illness or major surgery
chronic pain or orthopedic condition restricting exercise
active cancer, excluding basal cell cancer
anemia (HCT <30)
pregnancy
myasthenia gravis exacerbation in past 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charlene Hafer-Macko, MD	Contact	410-328-3100		cmacko@grecc.umaryland.edu

Overall Officials

Name	Affiliation	Role
Charlene E Hafer-Macko, MD	Baltimore VA Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland and Baltimore VA Medical Center	Recruiting	Baltimore	Maryland	21201	United States

References Module

Citations

Not provided

Label	URL
Myasthenia Gravis Foundation of America	View source
University of Maryland Myasthenia Gravis Center	View source

ID	Term
D009157	Myasthenia Gravis
D009043	Motor Activity

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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