Clinical Trial: Blood-flow Restricted Exercise in Inclusion Body Myositis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Low-intensity Blood-flow Restricted Muscle Exercise in Patients With Sporadic Inclusion Body Myositis: a Randomised Controlled Trial

Brief Summary: This study evaluates the effects of a low-intensity blood-flow restricted exerciser protocol on patient reported physical function, in patients with sporadic inclusion body myositis. The study is designed as a parallel group randomized controlled trial with a treatment group and a control group.

Detailed Summary:

Sporadic inclusion body myositis (sIBM) is a disease characterized by skeletal muscle inflammation and severe muscle atrophy especially in the muscles in the thigh and the finger flexors. In time the muscle weakness will cause the affected person to become unable to walk and carry out basic tasks in the every day life.

Currently no effective treatment exist for sIBM patients, however several studies indicate that exercise may be beneficial for the patients.

In the resent years a lot of research attention has been directed toward low-intensity training with partial vascular occlusion as an alternative to the conventional high intensity strength training. Interestingly the low-intensity blood-flow occluded training is found to be at least as beneficial in causing muscle growth as the conventional strength training but with very little mechanical load on joints and tendons. Furthermore the blood-flow occluded training seem to result in a hyper-activation of muscle stem cells which play an important role in muscle regeneration.

This make the blood-flow restricted training modality a very interesting treatment possibility for sIBM patients because it might be able to restore and/or maintain the skeletal muscle tissue and therefore also muscle function.


Sponsor: University of Southern Denmark

Current Primary Outcome: Patient reported physical function (health survey (SF-36) subscale: Physical Function) [ Time Frame: 12 wks ]

Patient reported physical function will be evaluated with the short form (36) health survey (SF-36) subscale: Physical Function. The scale ranges from 0 to 100 where 100 is the highest score.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Myositis Disease Activity Assessment Tool (MDAAT) [ Time Frame: 12 wks ]
    An assessment tool used by the physician to evaluate disease activity in various organ systems via a scoring system and VAS scales.
  • Myositis Damage Index [ Time Frame: 12 wks ]
    An assessment tool used by the physician to evaluate the damage caused by the disease or co-morbid conditions, to various organ systems. The system uses VAS scales.
  • Physician/Patient Global activity (VAS scale) [ Time Frame: 12 wks ]
    A VAS scale used by both physician and patient to evaluate the overall activity of the disease
  • Physician/Patient Global Damage (VAS scale) [ Time Frame: 12 wks ]
    A VAS scale used by both physician and patient to evaluate the overall damage caused by the disease.
  • 2-min walk test [ Time Frame: 12 wks ]
    A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.
  • Manual Muscle Testing (MMT) [ Time Frame: 12 wks ]
    A test of muscle strength in a series of muscles, carried out by the physician
  • Chair rise [ Time Frame: 12 wks ]
    Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.
  • Timed up & go [ Time Frame: 12 wks ]
    Participants are instructed to rise from a chair walk 3 m forward, pass a marking and return to the chair and sit down as fast as possible
  • Health assessment questionnaire (HAQ) [ Time Frame: 12 wks ]
    HAQ is a questionnaire to evaluate patient reported disability. It has 8 categories with a range of questions. Each question is scored from 0 to 3 where 0 is no disability and 3 is unable to do.
  • Inclusion body myositis functional rating scale (IBMFRS) [ Time Frame: 12 wks ]
    A disease specific questionnaire evaluating the patients self reported everyday function.


Original Secondary Outcome:

  • Myositis Disease Activity Assessment Tool (MDAAT) [ Time Frame: 12 wks ]
    An assessment tool used by the physician to evaluate disease activity in various organ systems via a scoring system and VAS scales.
  • Myositis Damage Index [ Time Frame: 12 wks ]
    An assessment tool used by the physician to evaluate the damage caused by the disease or co-morbid conditions, to various organ systems. The system uses VAS scales.
  • Physician/Patient Global activity (VAS scale) [ Time Frame: 12 wks ]
    A VAS scale used by both physician and patient to evaluate the overall activity of the disease
  • Physician/Patient Global Damage (VAS scale) [ Time Frame: 12 wks ]
    A VAS scale used by both physician and patient to evaluate the overall damage caused by the disease.
  • 2-min walk test [ Time Frame: 12 wks ]
    A 2-min maximal walk test where the participant is encouraged to cover the greatest distance possible.
  • Manual Muscle Testing (MMT) [ Time Frame: 12 wks ]
    A test of muscle strength in a series of muscles, carried out by the physician
  • Sway - Postural Balance (using force plate) [ Time Frame: 12 wks ]
    The participants are placed on a force plate and instructed to stand as steady as possible. The distance covered by the centre of pressure is analyzed and used as an indication of postural balance.
  • Leg extension muscle power (Nottingham Power Rig) [ Time Frame: 12 wks ]
    The Nottingham Power Rig is used for evaluating the maximal muscle power that can be generated in the leg extensors.
  • Maximal isometric and dynamic knee extension muscle strength (Kin-Com dynamometer) [ Time Frame: 12 wks ]
    The maximal isometric and dynamic knee extension muscle strength will be evaluated in a Kin-Com dynamometer. Isometric strength data will be analyzed for peak torque, maximal impulse and maximal contractile rate of force development (RFD)
  • Central activation (assessed with the twitch interpolation technique) [ Time Frame: 12 wks ]
    Voluntary muscle activation will be assessed with the twitch interpolation technique.
  • Body composition ( full body duel energy X-ray absorption scan [ Time Frame: 12 wks ]
    Body composition will be evaluated with a full body duel energy X-ray absorption scan.
  • Blood samples (analysis of markers of af disease activity) [ Time Frame: 12 wks ]
    Blood samples will be drawn for the analysis of markers of af disease activity: creatine kinase, lactate dehydrogenase, c-reactive protein, creatinine and alanine aminotransferase
  • Chair rise [ Time Frame: 12 wks ]
    Participants are instructed to stand up and sit down on a chair as many times as possible in 30 sec.
  • Timed up & go [ Time Frame: 12 wks ]
    Participants are instructed to rise from a chair walk 3 m forward, pass a marking and return to the chair and sit down as fast as possible
  • Health assessment questionnaire (HAQ) [ Time Frame: 12 wks ]
    HAQ is a questionnaire to evaluate patient reported disability. It has 8 categories with a range of questions. Each question is scored from 0 to 3 where 0 is no disability and 3 is unable to do.
  • Inclusion body myositis functional rating scale (IBMFRS) [ Time Frame: 12 wks ]
    A disease specific questionnaire evaluating the patients self reported everyday function.


Information By: University of Southern Denmark

Dates:
Date Received: December 10, 2014
Date Started: January 2015
Date Completion:
Last Updated: October 19, 2015
Last Verified: October 2015