Aerobic Training in Patients With Spinal Muscular Atrophy... | NCT02003937

Studies
Aerobic Training in Patients With Spinal Muscular Atrophy Type III

NCT02003937

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Oct 29, 2015Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Spinal Muscular Atrophy

Interventions

Aerobic conditioning

Countries

Denmark

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 2015

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

Sep 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Aug 22, 2013

First Submission Date that Met QC Criteria

Dec 2, 2013

First Posted Date

Dec 6, 2013Estimated

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, 2015

Last Update Posted Date

Oct 29, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Karen Lindhardt Madsen, M.Sc, Rigshospitalet, DenmarkPrincipal Investigator

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Not provided

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

Spinal muscular atrophy type III, (SMAIII) is a disease in the nerve cells in the spinal cord which leads to to progressive muscle weakness and atrophy. No effective treatment is available for SMA. We have previously shown that patients with muscular dystrophies improve oxidative capacity (VO2max), muscle strength and daily function by aerobic conditioning. Patients with SMAIII share many clinical features with these conditions, although the mechanism of muscle weakness is different. In this study, we investigated how patients with SMAIII respond to aerobic training.

6 patients and 9 healthy age- and sex-matched controls completed a 12 weeks training program. Subjects performed a total of 42 training session of 30 min on a stationary cycle ergometer at home. The work intensity was moderate and set to match a target heart rate.

Training induced an increase without inducing muscle damage. However, training-induced fatigue was a major complaint in all patients, and caused one patient to drop out, increased the need for sleep in three patients and two had to modify the training program.

The fatigue limits the use of this therapy. The training-induced fatigue, which is not encountered in muscle diseases, warrants investigations into alternative training methods to improve quality of life in patients with SMAIII.

Detailed Description

Spinal muscular atrophy type III, (SMAIII) is a recessively inherited disease in the lower motor neuron in the anterior horn of spinal cord leading to to progressive muscle weakness and atrophy. Currently there is no effective treatment available for SMA. We have previously shown that patients with muscular dystrophies improve oxidative capacity (VO2max), muscle strength and daily function by aerobic conditioning. Patients with SMAIII share many clinical features with these conditions, although the mechanism of muscle weakness is different. In this study, we investigated how patients with SMAIII respond to aerobic training.

VO2max was measured during a incremental exercise test using indirect calorimetry before and after the training period. Functional tests adressing patients walking and stair climbing abilities, were performed before and after the training period. Changes in activities of daily living was adressed in a standardized questionnaire after the training period.

Training induced an increase without inducing muscle damage. There were no changes in patients' functional capacities. However, training-induced fatigue was a major complaint in all patients, and caused one patient to drop out, increased the need for sleep in three patients and two had to modify the training program.

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
12 weeks of aerobic conditioning	Experimental	12 weeks of aerobic conditioning, a total 42 sessions of 30min exercise on a stationary cycle ergometer	Behavioral: Aerobic conditioning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aerobic conditioning	Behavioral	Subjects performed 12 weeks of aerobic training on a stationary cycle ergometer. Subjects compleeted a total of 42 training sessions of 30min. exercise at an individually adjusted moderate workload.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in oxidative capacity with aerobic conditioning in SMAIII patients		After 12 weeks of aerobic training

Secondary Outcomes

Measure	Description	Time Frame
Changes in maximal workload capacity with aerobic conditioning in SMAIII patients	The maximal workload capacity was defined as: The maximal resistance the subject was able to work at, during an incremental load exercise test, performed on a cycle ergometer.	After 12 weeks of aerobic conditioning
Changes in isometric muscle strength with aerobic conditioning in SMAIII patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Genetically verified SMAIII

Exclusion Criteria:

other serious medical conditions that could confound the interpretation of results and
regular exercise more than one hour weekly

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen L Madsen, M.Sc	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet, Neuromuscular Research Unit, 3342		Copenhagen E		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009134	Muscular Atrophy, Spinal

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided