Effect of Resistance and Aerobic Exercise in CIDP or MMN

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT02121678

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

11.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Demyelinating Polyneuropathy Multifocal Motor Neuropathy	Other: Resistance training Other: Aerobic training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

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 Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 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) 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.
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 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) 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.

Arm

Intervention/Treatment

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

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)

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.

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

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change in Medical Research Council (MRC) [-12, 0, 6, 12, 18, 24 weeks]
Change in Overall Disability Sum Score (ODSS) [-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 Quality of Life measured by The Short Form (36) Health Survey (SF-36) questionnaire [-12, 0, 6, 12, 18, 24 weeks]
Change in Fatigue Severity Score (FSS) [-12, 0, 6, 12, 18, 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, Aarhus University Hospital	Aarhus C		Denmark	8000
2	Department of Neurology, Rigshospitalet, Copenhagen University Hospital	Copenhagen		Denmark	2100