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Effect of Resistance and Aerobic Exercise in CIDP or MMN

Not Applicable
Completed
Conditions
Chronic Inflammatory Demyelinating Polyneuropathy
Multifocal Motor Neuropathy
Interventions
Other: Resistance training
Other: Aerobic training
Registration Number
NCT02121678
Lead Sponsor
University of Aarhus
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
23
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Run-in - Aerobic - ResistanceResistance training* 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
Run-in - Resistance - AerobicAerobic training* 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
Run-in - Aerobic - ResistanceAerobic training* 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
Run-in - Resistance - AerobicResistance training* 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
Primary Outcome Measures
NameTimeMethod
Changes in maximal oxygen consumption (VO2-max)-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

Changes in isokinetic muscle strength-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

Secondary Outcome Measures
NameTimeMethod
Change in Overall Disability Sum Score (ODSS)-12, 0, 6, 12, 18, 24 weeks
Change in Medical Research Council (MRC)-12, 0, 6, 12, 18, 24 weeks
Change in Quality of Life measured by The Short Form (36) Health Survey (SF-36) questionnaire-12, 0, 6, 12, 18, 24 weeks
Change in 6-Minute Walk test-12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
Change in Fatigue Severity Score (FSS)-12, 0, 6, 12, 18, 24 weeks

Trial Locations

Locations (2)

Department of Neurology, Aarhus University Hospital

🇩🇰

Aarhus C, Denmark

Department of Neurology, Rigshospitalet, Copenhagen University Hospital

🇩🇰

Copenhagen, Denmark

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