Effect of Resistance and Aerobic Exercise in CIDP or MMN

May 11, 2016 updated by: University of Aarhus

Effect of Resistance and Aerobic Exercise on Muscle Strength, Aerobic Capacity and Quality of Life in Patients Treated With Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) or Multifocal Motor Neuropathy (MMN)

Resistance and aerobic exercise has been shown to be effective for maintenance of muscle strength in patients with neuromuscular diseases.

Exercise in CIDP and MMN is sparsely described. The aim of the study is to evaluate changes in muscle strength during high intensive resistance training and changes in maximal oxygen consumption (VO2-max) during high intensive aerobic training in patients with CIDP or MMN in maintenance therapy with subcutaneous immunoglobulin.

The hypotheses are that muscle strength and VO2-max are significantly increased during the training sessions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Department of Neurology, Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Department of Neurology, Rigshospitalet, Copenhagen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 and < 80 years
  • Diagnosed with definite or probable CIDP or definite or probable MMN fulfilling the European Federation of Neurological Sciences/Peripheral Nerve Society (EFNS/PNS) criteria
  • Stable maintenance therapy with immunoglobulin (no change of dosage < 3 months before inclusion)
  • Duration of CIDP or MMN > 6 months
  • Negative result on a pregnancy test (HCG-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study

Exclusion Criteria:

  • Other cause of neuropathy (incl. pressure neuropathy)
  • Exercise before enrolment (> 1 hour of exercise per week or > 4 km bicycling per day)
  • Walking distance < 10 meter with or without aid
  • Diabetes mellitus, severe cardiac or pulmonary disease, malignancies
  • Known history of adverse reactions to Immunoglobulin A in other products
  • Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products.
  • History of malignancies of lymphoid cells and immunodeficiency with lymphoma
  • Known liver function impairment (ALAT 3 times above upper limit of normal)
  • Known protein-losing enteropathies or proteinuria.
  • Known of renal function impairment (creatinine >120 micromol/L or creatinine >1.35 mg/dL), or predisposition for acute renal failure (e.g., any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
  • Treatment with any investigational medicinal product within 3 months prior to first infusion of Gammanorm
  • Known or suspected HIV, Hepatitis Virus C or B infection
  • Pregnant or nursing women
  • Planned pregnancy during course of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Run-in - Aerobic - Resistance
  • Week -12 to 0: Run-in period with no training
  • Week 0 to 12: Aerobic training on ergometer bicycle
  • Week 12 to 24: Resistance training with dumbbells
Other: Resistance training

Participants do resistance training of selected muscle groups. Resistance are predefined from 1-repetition max (1-RM) and increased during the 12 weeks of training:

  • Week 0-4: 70-80 % of 1-RM
  • Week 5-8: 75-86 % of 1-RM
  • Week 9-12: 80-92% of 1-RM

Participants trains unilateral, the opposite site serves as reference.

  • MMN patients train elbow (flexion/extension) and wrist (flexion/extension)
  • CIDP patients train knee (flexion/extension) and elbow (flexion/extension)
Other: Aerobic training

Participants train on ergometer bicycle 2 times weekly increasing during the first weeks to 3 times weekly. Workload is measured before initiation and VO2-max, heart rate and blood pressure will be measured as well.

Patients train with 60-75 % of VO2-max for 30 minutes per training session. They use heart rate monitor to store data.
Experimental: Run-in - Resistance - Aerobic
  • Week -12 to 0: Run-in period with no training
  • Week 0 to 12: Resistance training with dumbbells
  • Week 12 to 24: Aerobic training on ergometer bicycle
Other: Resistance training

Participants do resistance training of selected muscle groups. Resistance are predefined from 1-repetition max (1-RM) and increased during the 12 weeks of training:

  • Week 0-4: 70-80 % of 1-RM
  • Week 5-8: 75-86 % of 1-RM
  • Week 9-12: 80-92% of 1-RM

Participants trains unilateral, the opposite site serves as reference.

  • MMN patients train elbow (flexion/extension) and wrist (flexion/extension)
  • CIDP patients train knee (flexion/extension) and elbow (flexion/extension)
Other: Aerobic training

Participants train on ergometer bicycle 2 times weekly increasing during the first weeks to 3 times weekly. Workload is measured before initiation and VO2-max, heart rate and blood pressure will be measured as well.

Patients train with 60-75 % of VO2-max for 30 minutes per training session. They use heart rate monitor to store data.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in isokinetic muscle strength
Time Frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks

Changes in isokinetic muscle strength during resistance exercise. Four muscle groups bilateral are selected.

CIDP: Knee flexion/extension Elbow flexion/extension MMN: Elbow flexion/extension Wrist flexion/extension
-12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
Changes in maximal oxygen consumption (VO2-max)
Time Frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks

VO2-max are measured during the 12 weeks aerobic exercise session and at enrolment 12 weeks before start of exercise.

VO2-max are measured while the participant running on a ergometer bicycle by accumulation of exhaled air
-12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Medical Research Council (MRC)
Time Frame: -12, 0, 6, 12, 18, 24 weeks
-12, 0, 6, 12, 18, 24 weeks
Change in Overall Disability Sum Score (ODSS)
Time Frame: -12, 0, 6, 12, 18, 24 weeks
-12, 0, 6, 12, 18, 24 weeks
Change in 6-Minute Walk test
Time Frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
-12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
Change in Quality of Life measured by The Short Form (36) Health Survey (SF-36) questionnaire
Time Frame: -12, 0, 6, 12, 18, 24 weeks
-12, 0, 6, 12, 18, 24 weeks
Change in Fatigue Severity Score (FSS)
Time Frame: -12, 0, 6, 12, 18, 24 weeks
-12, 0, 6, 12, 18, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-200

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