Multiple Sclerosis Clinical Trial
Official title:
Ischemic Preconditioning, Exercise Tolerance and Multiple Sclerosis
Verified date | January 2024 |
Source | Sheffield Teaching Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Regular physical activity improves aspects such as physical fitness, fatigue, quality of life, gait and also reduces the rate of progression of disability in individuals with Multiple Sclerosis. However, individuals with multiple sclerosis are less physically active than the general population. The determinants of engaging in physical activity for individuals with multiple sclerosis include psychological factors like motivation, self-belief and self-regulatory constructs and physical factors like fatigue, weakness, pain and ataxia. Ischemic preconditioning is exposure of the body to brief periods of circulatory occlusion and re-perfusion to protect organs against ischemic injury. Recent studies have also shown that ischemic preconditioning also improves exercise performance in healthy participants. The primary aim and objective of this study is to see whether it is feasible to use Ischemic preconditioning to improve exercise performance in people with Multiple Sclerosis. The design for the study is a double blind randomized control trial. Forty patients with multiple sclerosis above 18 years of age and who have the ability to walk will be randomized to receive either Ischemic preconditioning or sham intervention. All participants will be identified by MS consultants and nurses from the MS clinic and Neuro Day Case Unit of the Royal Hallamshire Hospital in Sheffield. Participation will involve an additional 2 hours of the patients time.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Diagnosis of MS as per the McDonald's criteria 2. Aged 18 or older 3. Sufficient cognitive ability to give informed consent 4. Ability to walk for 6 minutes without rest 5. Resting Systolic BP of less than 170 mmHg Exclusion Criteria: 1. Cognitive difficulties in giving consent ad understanding the questionnaire 2. Inability to walk 3. Other systemic illness affecting exercise tolerance 4. Resting systolic BP of 170mmHg or more |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Hallamshire Hospital | Sheffield | South Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability to tolerate Ischaemic Preconditioning (IPC_ | Patients will be asked to indicate the tolerability of IPC using a visual analogue scale from 0-10 (0 no symptoms and 10 intolerable symptoms). | One day | |
Secondary | Perceived rate of exertion | The participant will be asked to grade the exertion of 6 minutes' walk using this scale. It is a valid and reliable tool for measuring the perceived exertion in people with MS | One day |
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