Effect of Resistance and Aerobic Exercise in CIDP or MMN

Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121678
• Other study ID #: 2013-200
• Status: Completed
• Phase: N/A
• First received: February 17, 2014
• Last updated: May 11, 2016
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyneuropathy
• Multifocal Motor Neuropathy
• Neuritis
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

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)
• 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.

Locations

Country	Name	City	State
Denmark	Department of Neurology, Aarhus University Hospital	Aarhus C
Denmark	Department of Neurology, Rigshospitalet, Copenhagen University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Change in Medical Research Council (MRC)		-12, 0, 6, 12, 18, 24 weeks	No
Secondary	Change in Overall Disability Sum Score (ODSS)		-12, 0, 6, 12, 18, 24 weeks	No
Secondary	Change in 6-Minute Walk test		-12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks	No
Secondary	Change in Quality of Life measured by The Short Form (36) Health Survey (SF-36) questionnaire		-12, 0, 6, 12, 18, 24 weeks	No
Secondary	Change in Fatigue Severity Score (FSS)		-12, 0, 6, 12, 18, 24 weeks	No