Multiple SclerosisNCT07118514
Effect of Resistance Training on Psychophysiological Indicators in People With Multiple Sclerosis
A study testing Progressive Resistance Training and Stretching and Relaxation Activities in people with Multiple Sclerosis, run by State University of Maringá at 1 site in Brazil.
Trial summary
This randomized controlled trial aims to investigate the effects of a supervised resistance training program on plasma levels of Brain-Derived Neurotrophic Factor (BDNF) and irisin in individuals diagnosed with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Progressive Resistance Training and Stretching and Relaxation Activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2024to 17 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2017 McDonald Criteria
- Expanded Disability Status Scale (EDSS) score between 1.0 and 6.0
- Age between 18 and 60 years
- Medical clearance to engage in physical exercise
- Ability to understand and provide written informed consent
- Stable pharmacological treatment for MS for at least 3 months prior to enrollment
- No MS relapses or corticosteroid use within 30 days before starting the intervention
Who cannot join
- Pregnancy or planning to become pregnant during the study period
- Severe musculoskeletal conditions contraindicating exercise
- Participation in another structured or systematic exercise program
- Visual, cognitive, or communication impairments that may hinder participation
- Use of orthopedic devices incompatible with the intervention protocols
- Any other condition that, in the opinion of the research team, may interfere with participation or compromise data integrity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Resistance Training Program on Immunological, Psychological, and Functional Indicators in People With Multiple Sclerosis: A Randomized Clinical Trial
This randomized controlled trial aims to investigate the effects of a supervised resistance training program on plasma levels of Brain-Derived Neurotrophic Factor (BDNF) and irisin in individuals diagnosed with multiple sclerosis (MS). The study will also examine secondary outcomes, including fatigue, quality of life, anxiety and depression symptoms, muscular strength, and functional capacity.
Participants will be randomly assigned to either an intervention or control group in a 2:1 allocation ratio. The intervention group will undergo a 12-week supervised resistance training program, while the control group will maintain their usual care without engaging in any structured exercise regimen. The trial will be non-blinded and involve assessments at baseline and after the 12-week intervention period.
Read more
Eligible participants must be adults (≥18 years), of any sex, with a confirmed diagnosis of MS by a neurologist, and currently undergoing disease-modifying therapy (DMT). Participants must not be engaged in any other structured physical exercise program, though symptom-management physiotherapy will be permitted. All participants should have sufficient mobility to complete the training sessions and assessments.
Exclusion criteria include the inability to perform the physical training or functional tests due to severe mobility restrictions, lack of standard pharmacological treatment for MS, or concurrent participation in other structured exercise programs.
Read the detailed description
This randomized controlled trial investigates the effects of a 20-week progressive resistance training program on psychophysiological parameters in individuals with multiple sclerosis (MS). The study compares a resistance-training intervention group with an active control group performing stretching and relaxation exercises, aiming to determine changes in hormonal, immunological, motor, and psychological outcomes.
MS is a chronic, immune-mediated demyelinating disease of the central nervous system, associated with neuroinflammation, neurodegeneration, and significant variability in clinical presentation. Common symptoms such as fatigue, depression, and motor impairment severely impact quality of life. Research suggests that exercise can promote neuroprotection, modulate inflammatory processes, and improve both physical and psychological well-being in this population.
The intervention is based on established exercise guidelines for mild to moderate MS and is adapted from protocols demonstrating safety and feasibility in this population. It seeks to investigate simultaneous effects on circulating biomarkers - including brain-derived neurotrophic factor (BDNF), irisin, vitamin D, cortisol, vascular endothelial growth factor (VEGF), nerve growth factor (NGF), neurotrophin-3 (NT-3), and neurotrophin-4 (NT-4) - alongside functional capacity, muscle strength, body composition, and validated measures of fatigue, quality of life, anxiety, depression, motivation, and habitual physical activity.
Assessments are conducted before and after the intervention period, with all laboratory analyses performed under standardized fasting and sample-processing conditions. Functional and psychological measures are obtained using validated instruments for the Brazilian population. Participants are monitored to ensure high adherence rates, with makeup sessions provided when possible.
This trial addresses a gap in the literature by jointly evaluating neurotrophic, hormonal, motor, and psychological responses to structured exercise in Brazilian individuals with MS, and by including an active control condition to account for the potential influence of social interaction and attention. The findings may inform future rehabilitation strategies and complement pharmacological management, contributing to improved patient outcomes.
- Conditions
- Multiple Sclerosis
- Being tested
- Progressive Resistance Training, Stretching and Relaxation Activities
- Keywords
- Multiple Sclerosis, BDNF, Irisin, Anxiety, Depression, Exercise, Quality of life, Fatigue
- Medical subject headings
- Multiple Sclerosis, Anxiety Disorders, Depression, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance TrainingBehavioural
Also called Resistance training, Weight Training, Strength Training
A 12-week supervised resistance training program, performed twice weekly for 50 minutes per session. Exercises are based on 1-repetition maximum (1-RM) tests, using fixed machines and progressive loads (50-65% of 1-RM). Exercises include leg press, leg curl, knee extension, chest press, biceps/triceps curls, seated row, and lat pulldown.
Stretching and Relaxation ActivitiesBehavioural
Also called Static Muscle Stretching, Dynamic Stretching, Flexibility Protocols
A 12-week supervised program focused on flexibility and relaxation, performed twice weekly for approximately 50 minutes. Includes static stretching of major muscle groups and guided breathing exercises aimed at reducing muscle tension and promoting mental relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Participants in this group will undergo a 12-week supervised resistance training program, twice a week for approximately 50 minutes per session. Exercises are performed on fixed machines and based on 1-repetition maximum (1-RM) tests, with progressive loads from 50% to 65% of 1-RM. Training includes leg press, leg curl, knee extension, chest press, biceps and triceps curls, seated row, and lat pulldown Receives: Behavioral: Progressive Resistance Training |
| Control Group | Active comparator | Participants in this group will engage in light stretching and relaxation sessions twice a week for 12 weeks. Each session lasts approximately 30-40 minutes and includes breathing exercises, stretching of major muscle groups, and guided relaxation. Receives: Behavioral: Stretching and Relaxation Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of cortisol, brain-derived neurotrophic factor (BDNF), and irisin.
Change in plasma concentrations of cortisol, BDNF and irisin, measured using enzyme-linked immunosorbent assay (ELISA).
Measured: - Baseline - 12 weeks
Secondary outcomes (11)
Muscle Strength (Dynamic and Isokinetic)
Change in maximal strength of lower and upper limbs assessed by one-repetition maximum (1-RM) tests in selected exercises (e.g., leg press, chest press), and by isokinetic dynamometry of the knee extensors and flexors.
Measured: - Baseline - 12 weeks
Functional Mobility
Change in mobility performance assessed by the Timed Up and Go (TUG) test.
Measured: - Baseline - 12 weeks
Isokinetic Muscle Strength (Lower Limbs)
Change in peak torque of knee extensors and flexors measured using isokinetic dynamometry at angular velocities of 60°/s and 180°/s.
Measured: - Baseline -12 weeks
Fatigue
Change in fatigue perception measured by the Modified Fatigue Impact Scale (MFIS).
Measured: - Baseline -12 weeks
Anxiety and Depression
Change in psychological symptoms assessed by the Hospital Anxiety and Depression Scale (HADS), including anxiety and depression subscales.
Measured: - Baseline -12 weeks
Health-Related Quality of Life
Change in quality of life assessed by the Multiple Sclerosis Impact Scale (MSIS-29)
Measured: - Baseline - 12 weeks.
Optimism
Change in dispositional optimism assessed by the Revised Life Orientation Test (LOT-R).
Measured: - Baseline - 12 weeks.
Perceived Barriers to Physical Activity
Change in perceived barriers assessed by the Barriers to Physical Activity Questionnaire (Petroski, 2000).
Measured: - Baseline .
Physical Activity Level
Change in habitual physical activity level assessed by the Baecke Habitual Physical Activity Questionnaire.
Measured: - Baseline
Motivation for Exercise
Change in motivation for physical activity assessed by the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3).
Measured: - Baseline
Trait Anxiety Levels
Assessment of trait anxiety levels using the State-Trait Anxiety Inventory - Trait subscale (STAI-T), validated for the Brazilian population. The instrument consists of 20 self-reported items rated on a Likert-type scale, with total scores ranging from 20 to 80 points; higher scores indicate greater trait anxiety.
Time Frame:
Measured: - At baseline (before randomization) -12 weeks from the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Aug 2024
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Model description
- Participants will be randomized in a 2:1 ratio to either an intervention group (supervised progressive resistance training) or a control group (light stretching and relaxation activities). The intervention will last 12 weeks, with two sessions per week. All outcomes will be assessed at baseline and post-intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of Maringá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cleverson José Bezerra Guedes, State University of Maringá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118514
- Sponsor's protocol ID
- 70726623.3.0000.0104
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Resistance Training Program on Immunological, Psychological, and Functional Indicators in People With Multiple Sclerosis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07118514
- Acronym / sponsor ID
- 70726623.3.0000.0104
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, BDNF, Irisin, Anxiety, Depression, Exercise, Quality of life, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- State University of MaringáUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 12 Aug 2025 (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.
This randomized controlled trial aims to investigate the effects of a supervised resistance training program on plasma levels of Brain-Derived Neurotrophic Factor (BDNF) and irisin in individuals diagnosed with multiple sclerosis (MS). The study will also examine secondary outcomes, including fatigue, quality of life, anxiety and depression symptoms, muscular strength, and functional capacity.
Participants will be randomly assigned to either an intervention or control group in a 2:1 allocation ratio. The intervention group will undergo a 12-week supervised resistance training program, while the control group will maintain their usual care without engaging in any structured exercise regimen. The trial will be non-blinded and involve assessments at baseline and after the 12-week intervention period.
Eligible participants must be adults (≥18 years), of any sex, with a confirmed diagnosis of MS by a neurologist, and currently undergoing disease-modifying therapy (DMT). Participants must not be engaged in any other structured physical exercise program, though symptom-management physiotherapy will be permitted. All participants should have sufficient mobility to complete the training sessions and assessments.
Exclusion criteria include the inability to perform the physical training or functional tests due to severe mobility restrictions, lack of standard pharmacological treatment for MS, or concurrent participation in other structured exercise programs.
Detailed description
This randomized controlled trial investigates the effects of a 20-week progressive resistance training program on psychophysiological parameters in individuals with multiple sclerosis (MS). The study compares a resistance-training intervention group with an active control group performing stretching and relaxation exercises, aiming to determine changes in hormonal, immunological, motor, and psychological outcomes.
MS is a chronic, immune-mediated demyelinating disease of the central nervous system, associated with neuroinflammation, neurodegeneration, and significant variability in clinical presentation. Common symptoms such as fatigue, depression, and motor impairment severely impact quality of life. Research suggests that exercise can promote neuroprotection, modulate inflammatory processes, and improve both physical and psychological well-being in this population.
The intervention is based on established exercise guidelines for mild to moderate MS and is adapted from protocols demonstrating safety and feasibility in this population. It seeks to investigate simultaneous effects on circulating biomarkers - including brain-derived neurotrophic factor (BDNF), irisin, vitamin D, cortisol, vascular endothelial growth factor (VEGF), nerve growth factor (NGF), neurotrophin-3 (NT-3), and neurotrophin-4 (NT-4) - alongside functional capacity, muscle strength, body composition, and validated measures of fatigue, quality of life, anxiety, depression, motivation, and habitual physical activity.
Assessments are conducted before and after the intervention period, with all laboratory analyses performed under standardized fasting and sample-processing conditions. Functional and psychological measures are obtained using validated instruments for the Brazilian population. Participants are monitored to ensure high adherence rates, with makeup sessions provided when possible.
This trial addresses a gap in the literature by jointly evaluating neurotrophic, hormonal, motor, and psychological responses to structured exercise in Brazilian individuals with MS, and by including an active control condition to account for the potential influence of social interaction and attention. The findings may inform future rehabilitation strategies and complement pharmacological management, contributing to improved patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 2:1 ratio to either an intervention group (supervised progressive resistance training) or a control group (light stretching and relaxation activities). The intervention will last 12 weeks, with two sessions per week. All outcomes will be assessed at baseline and post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: Progressive Resistance TrainingParticipants in this group will undergo a 12-week supervised resistance training program, twice a week for approximately 50 minutes per session. Exercises are performed on fixed machines and based on 1-repetition maximum (1-RM) tests, with progressive loads from 50% to 65% of 1-RM. Training includes leg press, leg curl, knee extension, chest press, biceps and triceps curls, seated row, and lat pulldown |
| Control Group | Active comparator | Behavioral: Stretching and Relaxation ActivitiesParticipants in this group will engage in light stretching and relaxation sessions twice a week for 12 weeks. Each session lasts approximately 30-40 minutes and includes breathing exercises, stretching of major muscle groups, and guided relaxation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2017 McDonald Criteria
- Expanded Disability Status Scale (EDSS) score between 1.0 and 6.0
- Age between 18 and 60 years
- Medical clearance to engage in physical exercise
- Ability to understand and provide written informed consent
Key exclusion criteria (6 listed)
- Pregnancy or planning to become pregnant during the study period
- Severe musculoskeletal conditions contraindicating exercise
- Participation in another structured or systematic exercise program
- Visual, cognitive, or communication impairments that may hinder participation
- Use of orthopedic devices incompatible with the intervention protocols
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 |
|---|---|---|
| Progressive Resistance TrainingAlso: Resistance training, Weight Training, Strength TrainingA 12-week supervised resistance training program, performed twice weekly for 50 minutes per session. Exercises are based on 1-repetition maximum (1-RM) tests, using fixed machines and progressive loads (50-65% of 1-RM). Exercises include leg press, leg curl, knee extension, chest press, biceps/triceps curls, seated row, and lat pulldown. | Behavioural | Exercise Group |
| Stretching and Relaxation ActivitiesAlso: Static Muscle Stretching, Dynamic Stretching, Flexibility ProtocolsA 12-week supervised program focused on flexibility and relaxation, performed twice weekly for approximately 50 minutes. Includes static stretching of major muscle groups and guided breathing exercises aimed at reducing muscle tension and promoting mental relaxation. | Behavioural | Control Group |
Primary outcome
Plasma levels of cortisol, brain-derived neurotrophic factor (BDNF), and irisin.
Time frame: - Baseline - 12 weeks
Change in plasma concentrations of cortisol, BDNF and irisin, measured using enzyme-linked immunosorbent assay (ELISA).
11 secondary outcomes
Muscle Strength (Dynamic and Isokinetic)
Time frame: - Baseline - 12 weeks
Functional Mobility
Time frame: - Baseline - 12 weeks
Isokinetic Muscle Strength (Lower Limbs)
Time frame: - Baseline -12 weeks
Fatigue
Time frame: - Baseline -12 weeks
Anxiety and Depression
Time frame: - Baseline -12 weeks
Health-Related Quality of Life
Time frame: - Baseline - 12 weeks.
Optimism
Time frame: - Baseline - 12 weeks.
Perceived Barriers to Physical Activity
Time frame: - Baseline .
Physical Activity Level
Time frame: - Baseline
Motivation for Exercise
Time frame: - Baseline
Trait Anxiety Levels
Time frame: - At baseline (before randomization) -12 weeks from the start of the intervention
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 19 Aug 2025.
- Individual participant dataSharing planned: No
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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 Progressive Resistance Training and Stretching and Relaxation Activities in people with Multiple Sclerosis, run by State University of Maringá at 1 site in Brazil.
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 7 inclusion and 6 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 19 Aug 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 Brazil. 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?
Plasma levels of cortisol, brain-derived neurotrophic factor (BDNF), and irisin. (time frame: - Baseline - 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2025.