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CompletedNCT02121678Updated May 12, 2016

Effect of Resistance and Aerobic Exercise in CIDP or MMN

An interventional study of Resistance training and Aerobic training in Chronic Inflammatory Demyelinating Polyneuropathy and Multifocal Motor Neuropathy, sponsored by University of Aarhus. Completed at 2 sites in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-12.

Sponsored by University of Aarhus · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Inflammatory Demyelinating Polyneuropathy
  • Multifocal Motor Neuropathy

Keywords

  • Resistance training
  • Aerobic exercise
  • Isokinetic muscle strength
  • Bicycle ergometry test
  • Subcutaneous immunoglobulin
03

In context

Polyneuropathies

256 studies on the registry are indexed under Polyneuropathies; 50 are open to participants now.

This study's enrollment of 23 is below the median of 75 across 162 interventional studies indexed under Polyneuropathies.

Browse Polyneuropathies studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • 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 · Other: Aerobic training

  • 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 · Other: Aerobic training

Interventions

  • OtherResistance 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)

  • OtherAerobic 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.

06

What researchers measure

Primary outcomes

  1. Changes in isokinetic muscle strength

    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

    Time frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks

  2. Changes in maximal oxygen consumption (VO2-max)

    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

    Time frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks

Secondary outcomes

  1. Change in Medical Research Council (MRC)

    Time frame: -12, 0, 6, 12, 18, 24 weeks

  2. Change in Overall Disability Sum Score (ODSS)

    Time frame: -12, 0, 6, 12, 18, 24 weeks

  3. Change in 6-Minute Walk test

    Time frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks

  4. 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

  5. Change in Fatigue Severity Score (FSS)

    Time frame: -12, 0, 6, 12, 18, 24 weeks

07

Study locations

2 sites
  • Department of Neurology, Aarhus University Hospital
    Aarhus C, 8000, Denmark
  • Department of Neurology, Rigshospitalet, Copenhagen University Hospital
    Copenhagen, 2100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02121678
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Apr 23, 2014
Start date
Apr 2014
Primary completion
Dec 2015
Completion
Jan 2016
Last update
May 12, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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