Skip to main content
OpenTrials
Completed

NCT Number: NCT02121678

Effect of Resistance and Aerobic Exercise in CIDP or 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Immune System Diseases Multifocal Motor Neuropathy Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, Aarhus University Hospital, Aarhus C, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training

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

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.

Primary outcomes

  1. Changes in isokinetic muscle strength

    Time frame: -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

  2. Changes in maximal oxygen consumption (VO2-max)

    Time frame: -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 outcomes

  1. Change in Medical Research Council (MRC)

    Time frame: -12, 0, 6, 12, 18, 24 weeks

  2. Change in Overall Disability Sum Score (ODSS)

    Time frame: -12, 0, 6, 12, 18, 24 weeks

  3. Change in 6-Minute Walk test

    Time frame: -12, 0, 6, 12 weeks or -12, 0, 12, 18, 24 weeks

  4. Change in Quality of Life measured by The Short Form (36) Health Survey (SF-36) questionnaire

    Time frame: -12, 0, 6, 12, 18, 24 weeks

  5. Change in Fatigue Severity Score (FSS)

    Time frame: -12, 0, 6, 12, 18, 24 weeks

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 23, 2014
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.