Clinical trial NCT02121678: Effect of Resistance and Aerobic Exercise in CIDP or MMN
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
Multifocal Motor Neuropathy
Keywords: Resistance training
Aerobic exercise
Isokinetic muscle strength
Bicycle ergometry test
Subcutaneous immunoglobulin
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Changes in isokinetic muscle strength
timeFrame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
measure: Changes in maximal oxygen consumption (VO2-max)
timeFrame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
Secondary outcomes:
measure: Change in Medical Research Council (MRC)
timeFrame: -12, 0, 6, 12, 18, 24 weeks
measure: Change in Overall Disability Sum Score (ODSS)
timeFrame: -12, 0, 6, 12, 18, 24 weeks
measure: Change in 6-Minute Walk test
timeFrame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
measure: Change in Quality of Life measured by The Short Form (36) Health Survey (SF-36) questionnaire
timeFrame: -12, 0, 6, 12, 18, 24 weeks
measure: Change in Fatigue Severity Score (FSS)
timeFrame: -12, 0, 6, 12, 18, 24 weeks
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Neurology, Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Department of Neurology, Rigshospitalet, Copenhagen University Hospital
Study officials:
References: