None listed
Conditions
Brief summary
The study aims to analyse the effect of cooling, combined pre-cooling and cooling during exercise, in cycling with a passive cooling vest on core body temperature, heart rate, balance, physical capacity and fatigue of individuals with MS and general people.
Interventions
Subjects will attend 3 visits in the duration of the trial. Exercise sessions will be one-on-one supervised by an exercise physiologist or physiotherapist. Visit 1 will determine each individuals maximum exercise capacity. Baseline assessment will be conducted on a recumbent bike. After a 5 minute warm up of cycling with no resistance, participants will begin to cycle at a low workload (30 Watts for MS patients, 50 Watts for controls). After each completed minute of exercise, workload will be in
Subjects will attend 3 visits in the duration of the trial. Exercise sessions will be one-on-one supervised by an exercise physiologist or physiotherapist. Visit 1 will determine each individuals maximum exercise capacity. Baseline assessment will be conducted on a recumbent bike. After a 5 minute warm up of cycling with no resistance, participants will begin to cycle at a low workload (30 Watts for MS patients, 50 Watts for controls). After each completed minute of exercise, workload will be increased by 10 Watts. Maximum workrate is defined as the wattage at the last completed minute of exercise. Visits 2 and 3 will occur on days 7 and 14, allowing a 7 day wash out period between experiments. Participants will exercise for up to 30 minutes at 65% of their determined maximum while wearing a cooling vest cooled to either 10 degrees or 21 degrees. The vest will be worn for 30 minutes seated resting prior to exercise and during warm up and aerobic exercise. All participants (both MS and controls) will take part in both conditions.
Sponsors
Chris Barr
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
MS Subjects fulfilling the following criteria will be eligible to participate in this study: Definite diagnosis of MS; Mild to moderate difficulty in ambulation with Expanded Disability Status Scale (EDSS) 2.0 – 5.0; Able and agree to engage in maximal exercise test with minimal work load above 30 watts, which is the starting workload of graded incremental cycling test; Able to walk independently; Self-report in problem with fatigue; Able to understand instructions and give informed consent Inclusion criteria for healthy participants: Healthy male or female Over 18 years of age
Exclusion criteria
The exclusion criteria include: Use of medication prescribed for fatigue management (e.g Amantadine, Modafinil); Currently participates in other clinical trials or exercise program; Suffering from an exacerbation or relapse of MS within the past 3 months; Severe depression; Suffering form other neural, cardiovascular, orthopaedic or muscular disease besides MS; Gastroesophageal disease or dysphagia which has difficulty in swallowing the disposable silicon-coated pill to measure core temperature; Diverticulitis, which is a digestive disease could affect bowel and become contraindication to pill ingestion; Subject who is known to be pregnant; Subject with blood clotting problem prone to bleeding complications in blood lactate testing; Known illness or infection
Outcome results
None listed