Effect of Resistance and Aerobic Exercise in CIDP or MMN

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; Multifocal Motor Neuropathy
• Intervention / Treatment: Other: Resistance training; Other: Aerobic training

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Department of Neurology, Aarhus University Hospital
  • Copenhagen, Denmark, 2100
    • Department of Neurology, Rigshospitalet, Copenhagen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in isokinetic muscle strength	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	-12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks
Changes in maximal oxygen consumption (VO2-max)	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	-12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 17, 2014
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Aerobic exercise; Resistance training; Isokinetic muscle strength; Bicycle ergometry test; Subcutaneous immunoglobulin
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
• Other Study ID Numbers: 2013-200