Physical Exercise as a Targeted Therapy in Patients With... | NCT01184625

Studies
Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation

NCT01184625

Sponsor

Karolinska Institutet

Status

Unknown status

Last Update Posted

Jun 27, 2011Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Myositis

Interventions

Physical Exercise

Countries

Sweden

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

Jun 2011

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 2008

Primary Completion Date

Jan 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Aug 18, 2010

First Posted Date

Aug 19, 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

Jun 24, 2011

Last Update Posted Date

Jun 27, 2011Estimated

Name	Class
Uppsala University Hospital	OTHER
Sahlgrenska University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The objectives of this study are to test if hypoxia in muscle tissue is an important factor contributing to clinical symptoms in chronic rheumatic muscle inflammation and to evaluate if a 12 week endurance exercise program will improve muscle tissue hypoxia and disability in patients with chronic rheumatic muscle inflammation.

Detailed Description

Not provided

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

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		Other: Physical Exercise
No intervention	No Intervention	12 weeks of stable physical exercise level.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical Exercise	Other	12 weeks of physical exercise.	Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypoxia related metabolites.		At baseline before intervention.
Hypoxia related metabolites.		After 12 weeks of endurance exercise intervention/ non intervention.

Secondary Outcomes

Measure	Description	Time Frame
Muscle impairment.		At baseline before intervention.
Muscle impairment.		After 12 weeks of endurance exercise intervention/ non intervention.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with chronic, stable polymyositis or dermatomyositis with diagnosis of definite or probable polymyositis or dermatomyositis (Bohan and Peter 1975)
Age 18-80 years
Duration since diagnosis > 6 months
Exercising < once a week,
Stable disease activity and medication for at least one month.

Ten healthy controls matched for age, gender and physical exercise level will be included.

Exclusion Criteria:

Severe pulmonary fibrosis
Heart or lung conditions that contraindicate vigorous exercise
Severe osteoporosis
Not being able to perform the exercise program.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ingrid E Lundberg, MD, PhD, Prof	Contact	+46 8 517700	6087	ingrid.lundberg@ki.se

Overall Officials

Name	Affiliation	Role
Ingrid E Lundberg, MD, PhD, Prof	Rheumatology Unit, Department of Medicine, in Solna, Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rheumatology unit, Karolinska University Hospital	Recruiting	Stockholm			Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28829792	Derived	Boehler JF, Hogarth MW, Barberio MD, Novak JS, Ghimbovschi S, Brown KJ, Alemo Munters L, Loell I, Chen YW, Gordish-Dressman H, Alexanderson H, Lundberg IE, Nagaraju K. Effect of endurance exercise on microRNAs in myositis skeletal muscle-A randomized controlled study. PLoS One. 2017 Aug 22;12(8):e0183292. doi: 10.1371/journal.pone.0183292. eCollection 2017.
23941324

ID	Term
D009220	Myositis
D009043	Motor Activity

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

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