Clinical trial NCT06061939: Effects of Blood Flow Restriction Training on Middle-aged People With Multiple Sclerosis.
Official title: Effects of a Resistance Training Program Based on Blood Flow Restriction Training for People Over 45 Years of Age With Multiple Sclerosis on Muscle Strength and Functionality.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sclerosis, Multiple
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 94
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To analyze the effects of a resistance training program based on the blood flow restriction modality on muscle strengthening and functionality in people over 45 years of age with multiple sclerosis (MS).

Detailed description: This research corresponds to an experimental study, a double-blind randomized controlled clinical trial, where a total of blood flow (n = X) 12 weeks; and the control group (n= X) that will only receive general recommendations about the benefits of physical exercise. The variables will be measured for both groups with the same validated tools and the same researcher to avoid information bias and differential misclassification. The evaluations will be carried out at the beginning of the intervention and immediately after the end of this period, and the results will be noted in a data record that will later be unified in an Excel database, registering a code for each participant to maintain condition. of privacy, but at the same time allow the required comparability.

For the independent variables, sociodemographic characteristics, clinical history and the socio-familial assessment scale will be addressed; For their part, the result variables are divided by areas: those focused on the health status of patients with MS will measure the level of disability through the Expanded Disability Status Scale (EDSS), the impact of MS through the Multiple Sclerosis Impact Scale 29 (MSIS-29) and health-related quality of life (HRQoL) with the Short Form-36 (SF-36). For the physical condition variables, the Maximal Voluntary Isometric Contraction (MVIC) will be used with a dynamometer to measure general muscle strength and grip strength, as well as the Sit to Stand-5 repetitions (STS-5) and the Sit to Stand-5 repetitions (STS-5). 30 seconds (STS-30) to evaluate lower limb strength. For the functional variables, the impact on walking is evaluated using the Timed 25-Foot Walking Test (T25FWT); gait speed with the 10-Meters Walk Test (10-MWT) and Timed Up and Go (TUG); while walking endurance will be measured with the 6-Minute Walk Test (6-MWT). For its part, postural stability and balance from the Berg Balance Scale (BBS). To evaluate the level of physical activity, Godin Leisure-Time Exercise Questionnaire scores (GLTEQ) will be used. The questionnaire to determine fatigue will be the Fatigue Severity Scale (FSS) and the one in charge of measuring cognitive function will be the Symbol Digit Modalities Test (SDMT). On the other hand, in the psychological variables, the Hospital Anxiety and Depression Scale (HADS) will be applied for anxiety and depression and the Perceived Stress Scale (PSS) for the stress level. Finally, to measure sleep quality, the Pittsburgh Sleep Quality Index (PSQI) will be used. All variables will have pre and post intervention measurements. As a result, a training program with blood flow restriction is expected to improve the health status, muscle strength, functionality and psychological domains of middle-aged patients (\> 45 years) with MS, thus contributing to the comprehensive approach of this population. Once the intervention is completed, the final evaluation will be carried out and, based on the comparative process, define whether there are significant differences with respect to the results initially obtained.

Eligibility criteria: Inclusion Criteria:

* Male and female users over 45 years of age, who voluntarily agree to participate in the study, who are able to understand the instructions and exercise protocols of this project.

Exclusion Criteria:

* People with contraindications for performing physical tests or exercise. Users with a diagnosis of pathologies such as cancer, pulmonary hypertension and kidney failure, population with a diagnosis of heart disease or heart failure, population with a diagnosis and/or under psychiatric management, with neurological or cognitive alterations will be excluded. Population diagnosed with Human Immunodeficiency Virus infection or disease (HIV/AIDS). Population that does not agree to participate in the study or who, at the time of entering the program, have denied the endorsement of the use of their data for research in the informed consent.

Primary outcomes:
measure: Disability Status
timeFrame: Up to twelve weeks
measure: Multiple Sclerosis Impact
timeFrame: Up to twelve weeks
measure: Short Form-36 (SF-36).
timeFrame: Up to twelve weeks
measure: Muscle strength
timeFrame: Up to twelve weeks
measure: Gait impact
timeFrame: Up to twelve weeks
measure: Anxiety and depression
timeFrame: Up to twelve weeks
measure: Sleep quality
timeFrame: Up to twelve weeks
measure: Walking speed
timeFrame: Up to twelve weeks
measure: Physical fitness
timeFrame: Up to twelve weeks
measure: Walking endurance
timeFrame: Up to twelve weeks
measure: Balance and gait
timeFrame: Up to twelve weeks
measure: Multiple Sclerosis Quality of Life-54
timeFrame: Up to twelve weeks
measure: Executive functions
timeFrame: Up to twelve weeks
measure: Fatigue
timeFrame: Up to twelve weeks
Secondary outcomes:
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Up to twelve weeks
measure: Stress level
timeFrame: Up to twelve weeks
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: Up to twelve weeks
measure: Mini-Mental State Examination (MMSE)
timeFrame: Up to twelve weeks
measure: Chair sit and reach test
timeFrame: Up to twelve weeks
measure: Back scratch test
timeFrame: Up to twelve weeks
measure: Isaacs Test.
timeFrame: Up to twelve weeks
measure: Stoicism
timeFrame: Up to twelve weeks
measure: Hand coordination
timeFrame: Up to twelve weeks
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Asociación Jiennense de Esclerosis Múltiple
Study officials:
References: