Effect of Resistance and Aerobic Exercise in CIDP or MMN

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02121678
First received: February 17, 2014
Last updated: April 22, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Chronic Inflammatory Demyelinating Polyneuropathy
Multifocal Motor Neuropathy
Other: Resistance training
Other: Aerobic training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Changes in isokinetic muscle strength [ Time Frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks ] [ Designated as safety issue: No ]

    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


  • Changes in maximal oxygen consumption (VO2-max) [ Time Frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Change in Medical Research Council (MRC) [ Time Frame: -12, 0, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
  • Change in Overall Disability Sum Score (ODSS) [ Time Frame: -12, 0, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
  • Change in 6-Minute Walk test [ Time Frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in Fatigue Severity Score (FSS) [ Time Frame: -12, 0, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02121678

Contacts
Contact: Henning Andersen, DMSc +45 7846 3281 hennande@rm.dk
Contact: Lars H Markvardsen, MD +45 7846 3337 larsmark@rm.dk

Locations
Denmark
Department of Neurology, Aarhus University Hospital Not yet recruiting
Aarhus C, Denmark, 8000
Contact: Henning Andersen, DMSc       hennande@rm.dk   
Contact: Lars Markvardsen, MD    +45 7846 3337    larsmark@rm.dk   
Sub-Investigator: Lars Markvardsen, MD         
Principal Investigator: Henning Andersen, DMSc         
Department of Neurology, Rigshospitalet, Copenhagen University Hospital Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Ingelise Christiansen, PhD       ingelise.christiansen@regionh.dk   
Contact: Karen Heje Pedersen       karen.brorup.heje.pedersen.02@regionh.dk   
Principal Investigator: Ingelise Christiansen, PhD         
Sponsors and Collaborators
University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02121678     History of Changes
Other Study ID Numbers: 2013-200
Study First Received: February 17, 2014
Last Updated: April 22, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Resistance training
Aerobic exercise
Isokinetic muscle strength
Bicycle ergometry test
Subcutaneous immunoglobulin

Additional relevant MeSH terms:
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Demyelinating Diseases
Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014