Topic: Neurological
Conditions
Interventions
There are two arms to this study: a control arm and an intervention arm. Because the trial has a cross-over design, all participants will take part on both arms in a random order with an 8 week wash o
Sponsors
UCL and UCLH Clinical Research Facility (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of CMT or IBM 2. Male and female, aged 18 to 75 years 3. Able to walk for 30m with or without a walking aid or orthotic devices 4. Ability to safely mount/dismount an exercise bike unaided or standby assistance 5. Signed informed participant consent
Exclusion criteria
Exclusion criteria: 1. Presence of other significant neurological disorders (such as multiple sclerosis, cerebrovascular diseases, movement disorders), or major comorbidities (e.g. definite cognitive impairment, psychiatric disease, heart or lung failure, orthopaedic or rheumatological disorders) 2. Limb surgery during the six months prior to screening (or planned before final assessment) 3. Failure to pass the screening assessment outlined in the standardized operating procedure for exercise testing 4. Concurrent involvement in another intervention trial 5. People already participating in moderate to vigorous aerobic exercise more than three times per week 6. Aged over 75 or under 18 years 7. Women of child-bearing age onlyif they are pregnant at the inclusion into the study or plan to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal oxygen uptake (VO2 max); Timepoint(s): baseline, 12 weeks, 20 weeks and 32 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Impairment measures 1. Total Work (Watts/sec) and maximum power output (Watts) during exercise testing: measured from bicycle ergometer 2. Body composition and body mass index 3. Blood pressure and lung function (spirometry) 4. Fatigue severity: using the modified Fatigue Severity Scale (mFSS) 5. Disease severity: CMT Exam Score; IBM Functional Rating Scale 6. Lower limb muscle strength measures (isokinetic & isometric dynamometry) Functional measures 1. Walking speed: using a Timed 10m Walk Test at normal and maximal speeds 2. Six Minute Timed Walk Test: change in maximal walking distance in 6 minutes and peak heart rate 3. Perceived exertion during the Six Minute Timed Walk Test: using the Borg 15-point scale 4. Heart rate and Physiological Cost Index (PCI) during the Six Minute Timed Walk Test: using a heart rate monitor 5. Physical Activity monitoring over 7 days[1] Self reported measures 1. Gait performance: Walk12 scale 2. Fatigue using the mFSS 3. Self-efficacy for Management of Chronic Diseases Scale 4. Health related QOL: Short Form 36 scale 5. Barriers to Activity and Exercise: modified Barriers to Physical Activity and Disability Survey 6. International Physical Activity Questionnaire (IPAQ) 7. Sleep and Sleepiness using PSQI and ESS respectively Safety and monitoring 1. Blood plasma creatine kinase measurement 2. Pain: using the visual analogue scale (VAS) 3. Fatigue using the mFSS 4. Diary: to monitor mood and participation in the training regime | — |
Countries
United Kingdom
Outcome results
None listed