Effect of Resistance and Aerobic Exercise in CIDP or MMN

NCT ID: NCT02121678

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-01-31

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy; Multifocal Motor Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: OTHER

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)

Aerobic training

Intervention Type: OTHER

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.

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

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: OTHER

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)

Aerobic training

Intervention Type: OTHER

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.

Interventions

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)

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Neurology, Aarhus University Hospital

Aarhus C, , Denmark

Department of Neurology, Rigshospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

2013-200

Identifier Type: -

Identifier Source: org_study_id