Effects of Blood Flow Restriction Training on Middle-aged People With Multiple Sclerosis.

NCT ID: NCT06061939

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2024-06-07

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.

Conditions

Sclerosis, Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Group

A control group (CG) that will not undergo treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity, and they will be given the guide of recommendations for the promotion of physical activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

An experimental group (EG) that after an initial evaluation and with their consent, will be subjected to a directed physical training program, based on strength training with blood flow restriction, applied for 12 weeks with 3 weekly sessions (Monday, Wednesday and Friday), with a duration of 30-45 minutes per session. The exercises to be performed will be divided into three different phases: warm-up during the first 10 minutes; the main part with a duration of 15 minutes (where each exercise must be performed doing 4 series with a pattern of 30-15-15-15 repetitions, resting 30-45 seconds between series and 1-2 minutes between exercises); and the return to calm, based above all on stretching exercises with a total duration of 10 minutes.

Group Type: EXPERIMENTAL

Blood Flow Restriction training with Oclussion Cuff.

Intervention Type: OTHER

A strength training program with blood flow restriction will be performed for 12 weeks, with 30-45 minute sessions on Mondays, Wednesdays and Fridays. Each session includes a warm-up, the main part with specific exercises and a cool-down with stretching.

Interventions

Blood Flow Restriction training with Oclussion Cuff.

A strength training program with blood flow restriction will be performed for 12 weeks, with 30-45 minute sessions on Mondays, Wednesdays and Fridays. Each session includes a warm-up, the main part with specific exercises and a cool-down with stretching.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Agustín Aibar Almazán

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asociación Jiennense de Esclerosis Múltiple

Jaén, , Spain

Countries

Spain

Other Identifiers

University of Jaén*

Identifier Type: -

Identifier Source: org_study_id