Sclerosis, MultipleNCT06061939

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

A study testing Blood Flow Restriction training with Oclussion Cuff. in people with Sclerosis, Multiple, run by University of Jaén at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Sclerosis, Multiple
What is being tested?: Blood Flow Restriction training with Oclussion Cuff.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 1 siteSpain
Study dates: 5 Mar 2024to 7 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Asociación Jiennense de Esclerosis Múltiple
Jaén, 23440

Other trials in Spain

About this study

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.

Read the 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
Being tested: Blood Flow Restriction training with Oclussion Cuff.
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood Flow Restriction training with Oclussion Cuff.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.

Study groups in NCT06061939
Study group	Role	What they receive
Control Group	No intervention	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.
Intervention Group	Experimental	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. Receives: Other: Blood Flow Restriction training with Oclussion Cuff.

What is being measured

The primary outcome is the main question the study is designed to answer.

Disability Status
Expanded Disability Status Scale (EDSS). Method to quantify disability in multiple sclerosis and monitor changes in the level of disability over time. It is widely used in clinical trials and in the evaluation of people with MS. The EDSS scale ranges from 0 to 10 units with 0.5 point increments representing higher levels of disability. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory capacity and the later levels 5.0 to 9.5 refer to the loss of ambulatory capacity.
Measured: Up to twelve weeks
Multiple Sclerosis Impact
Multiple Sclerosis Impact Scale 29 (MSIS-29). It is a 29-item, condition-specific self-report questionnaire to measure the impact of MS on people's lives. It has two subscales: a 20-item physical impact scale and a 9-item psychological impact scale. It is currently in its second version, which has four-point response categories for each item: "not at all," "a little," "moderately," and "extremely." The physical impact scale can range from 20 to 80 and the psychological impact scale from 9 to 36, with lower scores indicating little impact of MS and higher scores indicating greater impact.
Measured: Up to twelve weeks
Short Form-36 (SF-36).
It is the most used scale for the general evaluation of health-related quality of life and consists of 36 items that are grouped into eight subscales or domains: (i) physical functioning (ten items); (ii) physical role (four items); (iii) body pain (two items); (iv) general health (five articles); (v) vitality (four items); (vi) social functioning (two items); (vii) emotional role (three items); and (viii) mental health (five items). The SF-36 also provides summary assessment for the physical and mental components (PCS and MCS, respectively). Higher scores reveal better overall HRQoL.
Measured: Up to twelve weeks
Muscle strength
Maximal Voluntary Isometric Contraction (MVIC) with the use of a dynamometer, a standardized method to measure muscle strength in patients with neuromuscular diseases5. Sit to Stand-5 repetitions (STS-5) along with Sit to Stand-30 seconds (STS-30) for MMII strength. In these tests, the patient must get up from a chair and measure the time it takes to perform 5 repetitions or quantify the number of repetitions that the patient is able to perform in 30 seconds6,7. For STS-5 the cut-off point is set at 9.4 sec. for those under 60 years of age; 11.4 sec. between 60 to 69 years old; 12.6 sec. 70 to 79 years and 14.9 sec. between 80 to 89 years, below these values there would be muscle dysfunction8. In the STS-30, scores lower than 8 repetitions imply muscle dysfunction.
Measured: Up to twelve weeks
Gait impact
Timed 25-Foot Walking Test (T25FWT). It consists of measuring the time required to travel a distance of 25 feet (7.5 meters). A time below 6 seconds means a functional gait, between 6 and 7.99 seconds means moderate gait dysfunction and 8 seconds or more means gait dysfunction.
Measured: Up to twelve weeks
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS). This scale consists of 14 items with 4 response alternatives ranging from 0 to 3 for a total of 0 to 21 points. It has 2 subscales and the score is obtained by adding the scores of each item that make it up, the interpretation criteria being the following: Range of normality (0-7), Possible case of anxiety or depression (8-10) and Case of anxiety or depression (11-21).
Measured: Up to twelve weeks
Sleep quality
Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-assessment questions or items and 5 more to be completed by the person with whom the participant shares a bed or room (although the latter is only used to provide clinical information). These items generate a total score and 7 components or domains: sleep quality; sleep latency; sleep duration; sleep efficiency; sleep disorders; use of sleeping medications; daytime dysfunction. The PSQI total score ranges from 0 to 21, with a higher score indicating poorer sleep quality.
Measured: Up to twelve weeks
Walking speed
10-Meters Walk Test (10-MWT) and Timed Up and Go (TUG). 10-MWT is used to measure walking speed and consists of measuring the time taken to travel 10 meters of distance11. The cut-off point is set by the walking speed in m/s, so there is no gait limitation if the speed is <0.40 m/s; moderate limitation if 0.40 to <0.80 m/s; and gait limitation ≥0.80 m/s12. On the other hand, the TUG consists of measuring the time it takes for the person to get up from a chair, walk 3 meters at their usual pace, turn around, return to the chair and sit down. 2 attempts are made and the best time is chosen. It is considered low risk of falling if the time is < 10 seconds, slight risk of falling if the time is between 10-20 seconds, and high risk of falling if the time is > 20 seconds.
Measured: Up to twelve weeks
Physical fitness
Godin Leisure-Time Exercise Questionnaire (GLTEQ). This questionnaire consists of 3 items divided according to the intensity of the exercises performed. For each item, a score is added based on the participant's response. The scores of the items will be added, considering that the physical activity carried out is Intense ≥ 24 units, Moderate ≥14 and ≤23 units and Light < 14 units.
Measured: Up to twelve weeks
Walking endurance
6-Minute Walk Test (6-MWT). Test commonly used for the objective evaluation of functional exercise capacity. The patient is asked to walk (minimum in a 30 meter hallway) for a period of 6 minutes, with the primary outcome measure being the distance walked in 6 minutes measured in meters. In general, normal ranges are between 400-700 meters, with a value below 400 meters being an indicator of low aerobic capacity and good above 700 meters.
Measured: Up to twelve weeks
Balance and gait
Tinetti. Completion time: 8-10 minutes. While walking behind the patient, the evaluator asks them to respond to the questions from the gait subscale. To answer the balance subscale, the interviewer stands next to the patient. A higher score indicates better functioning. The maximum score for the gait subscale is 12, and for the balance subscale, it is 16. The sum of both scores is used to assess the risk of falls. A higher score indicates a lower risk. A score of less than 19 signifies a high risk of falls.
Measured: Up to twelve weeks
Multiple Sclerosis Quality of Life-54
There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. In addition, there are 12 subscales: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. There are also two single-item measures: satisfaction with sexual function and change in health.
Measured: Up to twelve weeks
Executive functions
The Trail Making Test (TMT) will be used for the assessment of executive function and specifically measures timed visual and motor tasks. This test is divided into two parts: part A (TMT-A) is responsible for evaluating psychomotor attention and speed and consists of connecting consecutively numbered circles; and Part B (TMT-B), which is based on connecting alternating circles of letters and numbers and measures executive function. A longer time spent completing the test is interpreted as worse performance.
Measured: Up to twelve weeks
Fatigue
Fatigue Severity Scale (FSS). One of the most widely used self-report tools to assess fatigue. It is made up of nine elements (1 to 7). The average score of the nine items is used as the total score of the FSS. A higher score indicates greater severity of fatigue. MID ranges from 0.5 to 1.2 for FSS total score.
Measured: Up to twelve weeks

Secondary outcomes (9)

Symbol Digit Modalities Test (SDMT)
This test measures processing speed. The SDMT sheet consists of a header with a key that relates the numbers 1 to 9 with different symbols. Below is a template with several symbols that must be assigned the corresponding number. The patient completes the first ten boxes to familiarize himself and then has 90 seconds to complete the greatest number of boxes. 44 is considered the cut-off point, so scores below 44 imply abnormal cognitive functioning, with 44 points onwards being normal.
Measured: Up to twelve weeks
Stress level
Perceived Stress Scale (PSS). This scale is a self-report instrument that evaluates the level of perceived stress during the last month, it consists of 14 items with a response format of a five-point scale (0 = never, 1 = almost never, 2 = occasionally when, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10 and 13 (in the following sense: 0=4, 1=3, 2=2, 3=1 and 4 =0) and then adding the 14 items. The direct score obtained indicates that a higher score corresponds to a higher level of perceived stress.
Measured: Up to twelve weeks
MoCA (Montreal Cognitive Assessment)
Instrument that examines the skills of attention, concentration, executive functions, memory, language, visuoconstructive abilities, calculation and orientation and the maximum score is 30.
Measured: Up to twelve weeks
Mini-Mental State Examination (MMSE)
The most widely used cognitive screening test to assess suspected symptoms consistent with cognitive impairment or dementia. Written test with a maximum score of 30. The cut-off point established for the MMSE defines "normal" cognitive function is generally set at 24, lower scores indicate more serious cognitive problems.
Measured: Up to twelve weeks
Chair sit and reach test
To test low back and hamstring flexibility.
Measured: Up to twelve weeks
Back scratch test
To measure general shoulder range of motion.
Measured: Up to twelve weeks
Isaacs Test.
This test measures verbal fluency. The patient is asked to name as many elements as she can remember from each of the 4 categories: colors, animals, fruits and cities. One point is awarded for each correct item, with a maximum of 10 scoring items in each set. The patient has a maximum of 1 minute per category. Repetitions or names that do not belong to the requested category do not score, although it is useful to note the number of such cases. Always write down the names that the patient mentions, as this will help in evaluating the patient's progress. The score ranges between 0 and 40 points. The cut-off point for detecting dementia, in the Spanish validation, is equal to or less than 29 in adults, and equal to or less than 27 in older people. Furthermore, a cut-off point of 25 is proposed to consider probable Alzheimer's dementia, with a sensitivity of 87% and a specificity of 67%, resulting in a misclassification rate of 24%.
Measured: Up to twelve weeks
Stoicism
Liverpool Stoicism Scale. The LSS is a self-reported questionnaire designed to measure stoicism; it consists of 20 items whose content refers to lack of emotional involvement, dislike for openly expressing emotion, and the ability to withstand emotion. Responses were recorded on a 5-point Likert scale ranging from strongly disagree to strongly agree. To prevent response bias, half of the questions were posed in such a way that agreement was synonymous with high stoicism, whereas for the other half, disagreement indicated a high level of stoicism. The answers to these questions were evaluated in reverse. Ten items (1, 2, 5, 7, 9, 12, 13, 15, 17, and 18) are reverse-scored. The minimum sum score is 20 and the maximum is 100. Higher scores indicate greater stoicism levels. The original version is reported to have acceptable internal consistency.
Measured: Up to twelve weeks
Hand coordination
9 Hole Peg Test. The Nine Hole Peg Test is a simple and quick assessment tool that we occupational therapists use to evaluate manipulative dexterity, eye-hand coordination, and other upper limb functions in people with neurological impairments. It involves placing and removing nine pegs in the shortest possible time. The shorter the time, the better the score.
Measured: Up to twelve weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 20247 Jun 2024

First posted29 Sep 2023
Study start5 Mar 2024
Primary completion11 Mar 2024
Study completion7 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sclerosis, MultipleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06061939
Sponsor's protocol ID: University of Jaén*
Status last verified: May 2025
First submitted: 25 Sep 2023
Last updated: 30 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT06061939
Acronym / sponsor ID: University of Jaén*
Conditions: Sclerosis, Multiple
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: University of JaénUniversity, hospital or other
Study start: 5 Mar 2024 (actual)
Primary completion: 11 Mar 2024 (actual)
Study completion: 7 Jun 2024 (actual)
First posted: 29 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control Group	No intervention	–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.
Intervention Group	Experimental	Other: Blood Flow Restriction training with Oclussion Cuff.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.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	Intervention Group

Primary outcome

Disability Status
Time frame: Up to twelve weeks
Expanded Disability Status Scale (EDSS). Method to quantify disability in multiple sclerosis and monitor changes in the level of disability over time. It is widely used in clinical trials and in the evaluation of people with MS. The EDSS scale ranges from 0 to 10 units with 0.5 point increments representing higher levels of disability. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory capacity and the later levels 5.0 to 9.5 refer to the loss of ambulatory capacity.
Multiple Sclerosis Impact
Time frame: Up to twelve weeks
Multiple Sclerosis Impact Scale 29 (MSIS-29). It is a 29-item, condition-specific self-report questionnaire to measure the impact of MS on people's lives. It has two subscales: a 20-item physical impact scale and a 9-item psychological impact scale. It is currently in its second version, which has four-point response categories for each item: "not at all," "a little," "moderately," and "extremely." The physical impact scale can range from 20 to 80 and the psychological impact scale from 9 to 36, with lower scores indicating little impact of MS and higher scores indicating greater impact.
Short Form-36 (SF-36).
Time frame: Up to twelve weeks
It is the most used scale for the general evaluation of health-related quality of life and consists of 36 items that are grouped into eight subscales or domains: (i) physical functioning (ten items); (ii) physical role (four items); (iii) body pain (two items); (iv) general health (five articles); (v) vitality (four items); (vi) social functioning (two items); (vii) emotional role (three items); and (viii) mental health (five items). The SF-36 also provides summary assessment for the physical and mental components (PCS and MCS, respectively). Higher scores reveal better overall HRQoL.
Muscle strength
Time frame: Up to twelve weeks
Maximal Voluntary Isometric Contraction (MVIC) with the use of a dynamometer, a standardized method to measure muscle strength in patients with neuromuscular diseases5. Sit to Stand-5 repetitions (STS-5) along with Sit to Stand-30 seconds (STS-30) for MMII strength. In these tests, the patient must get up from a chair and measure the time it takes to perform 5 repetitions or quantify the number of repetitions that the patient is able to perform in 30 seconds6,7. For STS-5 the cut-off point is set at 9.4 sec. for those under 60 years of age; 11.4 sec. between 60 to 69 years old; 12.6 sec. 70 to 79 years and 14.9 sec. between 80 to 89 years, below these values there would be muscle dysfunction8. In the STS-30, scores lower than 8 repetitions imply muscle dysfunction.
Gait impact
Time frame: Up to twelve weeks
Timed 25-Foot Walking Test (T25FWT). It consists of measuring the time required to travel a distance of 25 feet (7.5 meters). A time below 6 seconds means a functional gait, between 6 and 7.99 seconds means moderate gait dysfunction and 8 seconds or more means gait dysfunction.
Anxiety and depression
Time frame: Up to twelve weeks
Hospital Anxiety and Depression Scale (HADS). This scale consists of 14 items with 4 response alternatives ranging from 0 to 3 for a total of 0 to 21 points. It has 2 subscales and the score is obtained by adding the scores of each item that make it up, the interpretation criteria being the following: Range of normality (0-7), Possible case of anxiety or depression (8-10) and Case of anxiety or depression (11-21).
Sleep quality
Time frame: Up to twelve weeks
Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-assessment questions or items and 5 more to be completed by the person with whom the participant shares a bed or room (although the latter is only used to provide clinical information). These items generate a total score and 7 components or domains: sleep quality; sleep latency; sleep duration; sleep efficiency; sleep disorders; use of sleeping medications; daytime dysfunction. The PSQI total score ranges from 0 to 21, with a higher score indicating poorer sleep quality.
Walking speed
Time frame: Up to twelve weeks
10-Meters Walk Test (10-MWT) and Timed Up and Go (TUG). 10-MWT is used to measure walking speed and consists of measuring the time taken to travel 10 meters of distance11. The cut-off point is set by the walking speed in m/s, so there is no gait limitation if the speed is <0.40 m/s; moderate limitation if 0.40 to <0.80 m/s; and gait limitation ≥0.80 m/s12. On the other hand, the TUG consists of measuring the time it takes for the person to get up from a chair, walk 3 meters at their usual pace, turn around, return to the chair and sit down. 2 attempts are made and the best time is chosen. It is considered low risk of falling if the time is < 10 seconds, slight risk of falling if the time is between 10-20 seconds, and high risk of falling if the time is > 20 seconds.
Physical fitness
Time frame: Up to twelve weeks
Godin Leisure-Time Exercise Questionnaire (GLTEQ). This questionnaire consists of 3 items divided according to the intensity of the exercises performed. For each item, a score is added based on the participant's response. The scores of the items will be added, considering that the physical activity carried out is Intense ≥ 24 units, Moderate ≥14 and ≤23 units and Light < 14 units.
Walking endurance
Time frame: Up to twelve weeks
6-Minute Walk Test (6-MWT). Test commonly used for the objective evaluation of functional exercise capacity. The patient is asked to walk (minimum in a 30 meter hallway) for a period of 6 minutes, with the primary outcome measure being the distance walked in 6 minutes measured in meters. In general, normal ranges are between 400-700 meters, with a value below 400 meters being an indicator of low aerobic capacity and good above 700 meters.
Balance and gait
Time frame: Up to twelve weeks
Tinetti. Completion time: 8-10 minutes. While walking behind the patient, the evaluator asks them to respond to the questions from the gait subscale. To answer the balance subscale, the interviewer stands next to the patient. A higher score indicates better functioning. The maximum score for the gait subscale is 12, and for the balance subscale, it is 16. The sum of both scores is used to assess the risk of falls. A higher score indicates a lower risk. A score of less than 19 signifies a high risk of falls.
Multiple Sclerosis Quality of Life-54
Time frame: Up to twelve weeks
There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. In addition, there are 12 subscales: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. There are also two single-item measures: satisfaction with sexual function and change in health.
Executive functions
Time frame: Up to twelve weeks
The Trail Making Test (TMT) will be used for the assessment of executive function and specifically measures timed visual and motor tasks. This test is divided into two parts: part A (TMT-A) is responsible for evaluating psychomotor attention and speed and consists of connecting consecutively numbered circles; and Part B (TMT-B), which is based on connecting alternating circles of letters and numbers and measures executive function. A longer time spent completing the test is interpreted as worse performance.
Fatigue
Time frame: Up to twelve weeks
Fatigue Severity Scale (FSS). One of the most widely used self-report tools to assess fatigue. It is made up of nine elements (1 to 7). The average score of the nine items is used as the total score of the FSS. A higher score indicates greater severity of fatigue. MID ranges from 0.5 to 1.2 for FSS total score.

9 secondary outcomes

Symbol Digit Modalities Test (SDMT)
Time frame: Up to twelve weeks
Stress level
Time frame: Up to twelve weeks
MoCA (Montreal Cognitive Assessment)
Time frame: Up to twelve weeks
Mini-Mental State Examination (MMSE)
Time frame: Up to twelve weeks
Chair sit and reach test
Time frame: Up to twelve weeks
Back scratch test
Time frame: Up to twelve weeks
Isaacs Test.
Time frame: Up to twelve weeks
Stoicism
Time frame: Up to twelve weeks
Hand coordination
Time frame: Up to twelve weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
Individual participant dataSharing planned: No

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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood Flow Restriction training with Oclussion Cuff. in people with Sclerosis, Multiple, run by University of Jaén at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability Status (time frame: Up to twelve weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06061939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.