Effect of Resistance and Aerobic Exercise in CIDP or MMN

University of Aarhus

Status: Completed

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; Multifocal Motor Neuropathy

Treatments: Other: Resistance training; Other: Aerobic training

Study type: Interventional

Funder types: Other

Identifiers

NCT02121678

2013-200

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

23 participants in 2 patient groups

Run-in - Aerobic - Resistance

Experimental group

Description:

* 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

Treatment:

Other: Resistance training

Other: Aerobic training

Run-in - Resistance - Aerobic

Experimental group

Description:

* 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

Treatment:

Other: Resistance training

Other: Aerobic training