Multiple SclerosisNCT05185986
Investigating the Home-based RCTs of Pilates Exercises and Cognitive Rehabilitation Exercises for Executive Functions and Anxiety in MS.
A study testing Home-Based Pilates exercise, Home-based Cognitive Rehabilitation and waiting list group in people with Multiple Sclerosis, run by Arak University of Medical Sciences at 1 site in Iran.
Trial summary
The main purpose of this study is to evaluate the effectiveness of home-based Pilates exercises and the combination of home-based Pilates exercises with home-based cognitive rehabilitation exercises, also to compare the effects of these two home-based interventions on executive functions and anxiety in MS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Home-Based Pilates exercise, Home-based Cognitive Rehabilitation and waiting list group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIran
- Study dates
- 20 Dec 2021to 7 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physician-diagnosed Multiple Sclerosis
- EDSS score < 5
- Free from any other significant physical or psychiatric condition
- Have no previous Pilates experience
Who cannot join
- having cognitive or physical exercises at least from 3 months before intervention.
- Using psychiatric drugs or being under psychotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison the Home-based Pilates Exercises and the Combination of Home-based Pilates Exercises With Home-based Cognitive Rehabilitation Exercises on Executive Functions and Anxiety in Multiple Sclerosis Patients.
The main purpose of this study is to evaluate the effectiveness of home-based Pilates exercises and the combination of home-based Pilates exercises with home-based cognitive rehabilitation exercises, also to compare the effects of these two home-based interventions on executive functions and anxiety in MS patients. 51 MS patients of Isfahan MS society will be considered as sample and will be divided randomly into three groups of 17 participants. The first group is home-based Pilates exercises group, the second group is a combination of home-based Pilates exercises and home-based cognitive rehabilitation exercises and the third group is the waiting list group that is considered as the control group. Patients' scores on executive functions and anxiety will be assessed before and after 8 weeks of intervention.
Read the detailed description
Since the onset of pandemic conditions in 2020 and the increase of lockdowns, almost all rehabilitation programs for MS patients in Iran were suspended, it is necessary to study the effects of home-based cognitive and physical interventions to improve executive functions and anxiety in MS patients. The present study will be conducted to investigate the effects of home-based Pilates exercises and the combination of home-based Pilates exercises with home-based cognitive rehabilitation as well as to compare the effects of these two interventions on executive functions and anxiety in MS patients. In this study, participants will be divided into two experimental groups and a control group. The research process and the reason for conducting the research will be explained to the candidates by lead researcher and the final participants will sign the research participation form. All 51 final participants will be identified by a code and their identity information will not be disclosed, and in order to avoid any bias, each code will be randomly divided into three groups randomly. Pre-test will be taken from all three groups before the intervention. Experiment group 1 will perform a home-based Pilates video training program for 8 weeks, two sessions a week at home, and will also pay attention to exercise-related tips for MS patients determined by specialists. At the same time, Experiment group 2 will be asked to perform home-based cognitive rehabilitation program for 8 weeks, 3 seasons a week at home, in addition to home-based Pilates exercises same as experimental group 1. Group 3 will also be on the waiting list as a control group and will not receive any interventions for 8 weeks. At the end of 8 week intervention, Pilates training packages and cognitive exercises will be provided to the control group for their own use. During the 8 weeks of the intervention, the Pilates instructor and the cognitive rehabilitation specialist will contact the subjects on a weekly basis and monitor their performance. Subjects will also be able to contact the researchers and express their questions and problems. Also, they will be able to hold online meetings with research facilitators for solving the problems and educating the exercises. During the 8 weeks of the intervention, if subjects have problems such as COVID-19 affection, coronary heart disease, muscle problems, relapse, and failure to perform more than 4 sessions of exercise, they will be excluded from the study by the lead researcher. In order to fully perform the exercises for people who do not perform up to 4 sessions of exercises, 2 weeks can be added to the intervention period, which will be applied by the lead researcher. After complete implementation of the intervention, post-test will be taken from all 3 groups and the results will be compared to the baseline and relative to each other.
- Conditions
- Multiple Sclerosis
- Being tested
- Home-Based Pilates exercise, Home-based Cognitive Rehabilitation, waiting list group
- Keywords
- Multiple sclerosis, Executive Functions, Anxiety, Pilates, Cognitive Rehabilitation
- Medical subject headings
- Multiple Sclerosis, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Pilates exerciseBehavioural
The Home-based Pilates is the two Pilates classes at home, twice weekly, for a period of eight weeks.
Home-based Cognitive RehabilitationOther
Home-based Cognitive Rehabilitation is the 3 sessions per week and 8 weeks of cognitive rehabilitation exercises at home. Each session consists of two Pen and paper exercises. Exercises are active in the areas of planning, cognitive organization, cognitive flexibility and working memory. Each session will take 30 to 45 minutes.
waiting list groupOther
This group act as the control group and will maintain their physical and cognitive activities as the preintervention. Following the 8 weeks of intervention the home-based pilates and cognitive rehabilitation exercises will be provided to them for their own use.
| Study group | Role | What they receive |
|---|---|---|
| Home based Pilates exercises | Experimental | This group will perform two weekly sessions of Pilates for eight weeks, completed with at least 48-hours between sessions, in their own home, supported by a DVD developed and previously implemented and evaluated by the lead researcher in a feasibility trial among people with Multiple Sclerosis. Each Pilates session will last approximately one hour and is comprised of seven Pilates warm-up exercises and fourteen mat-based beginner's level exercise. Four repetitions of each Pilates movement will be performed during sessions in the first two weeks, with intensity being self-regulated by the participant based on level of physical condition. Repetitions will gradually progress at biweekly intervals, resulting in ten repetitions being performed for the final two weeks of the trial (Weeks 7 and 8). Six post-training stretches will be maintained for a minimum of thirty seconds. Receives: Behavioral: Home-Based Pilates exercise |
| Combination of Home-based Pilates exercises and Home-based Cognitive Rehabilitation exercises | Experimental | In addition to performing home-based Pilates exercises described in arm 1, this group will also perform home-based cognitive rehabilitation exercises for 8 weeks and 3 sessions per week. The interval between each session is at least 48 hours and each session will take between 30 to 45 minutes. Cognitive rehabilitation exercises are in pen and paper and each session includes two exercises in the areas of planning, cognitive organization, cognitive flexibility and working memory. All exercises will be explained to the subjects by a cognitive rehabilitation specialist, and in addition, explanations of all the exercises in each session will be available for participants in the separate voices. During the intervention period, in addition to the Pilates specialist, the cognitive rehabilitation specialist contacts the group 2 participants on a weekly basis and monitors their rehabilitation exercises. Receives: Behavioral: Home-Based Pilates exercise; Other: Home-based Cognitive Rehabilitation |
| Waiting list group | Other | This group is the waiting list group and acts as a control group and will be instructed to maintain their preintervention physical and cognitive activity levels during the intervention. After 8 weeks of intervention, Pilates exercises and cognitive rehabilitation exercises will be provided to the participants of this group for their own use. Receives: Other: waiting list group |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline total number of cWMI
Computerized Working Memory Index (cWMI) The computerized figures width subscale of the Wechsler IQ scale, is used to measure working memory. Figures Width is the working memory subscale of the fourth edition of the Wechsler Intelligence Scale, which consists of two parts: Forward Figures Width and Inverted Figures Width and The sum of a person's scores in these two parts constitutes the total score of the person in this subscale.
Measured: Baseline, week 8
change from baseline total time of cTOL
Computerized Tower Of London Task (cTOL) a computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards. Each baseline and 8 week set of 12 problems consists of the same number of 2, 3, 4 or 5 move problems and has the same average difficulty level. Every problem could be repeated 3 times to be solved by participants. The dependent variables are the total number of task and the total time spent solving the problem (less time is better) and the delayed time or time to first move (less time is better).
Measured: Baseline, week 8
change from baseline score of BAI
Beck Anxiety Inventory (BAI) Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".
Measured: Baseline, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start20 Dec 2021
- Primary completion28 Feb 2022
- Study completion7 Mar 2022
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arak University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Pardis Specialized Wellness Institute
- Responsible party
- Principal investigator, Amir Hossein Kazemi, Arak University of Medical Sciences
- Investigators
- Tooraj Sepahvand, Phd., Study director, University of ArakMohammad Ali Tabibi, Phd., Study chair, Islamic Azad University of KhorasganMasoud Etemadifar, Phd., Study chair, Isfahan University of Medical SciencesAmir Hossein Kazemi, MS., Principal investigator, University of Arak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185986
- Sponsor's protocol ID
- 6436
- Status last verified
- Mar 2022
- First submitted
- 23 Dec 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' identities will not be shared. Each participant is identified by a code and the data obtained from the assessment of the participants by the research tools and the demographic data of the participants including age, education, marital status and EDSS score will be available via the email of the principal researcher.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Home-based Pilates Exercises and the Combination of Home-based Pilates Exercises With Home-based Cognitive Rehabilitation Exercises on Executive Functions and Anxiety in Multiple Sclerosis Patients.
- ClinicalTrials.gov ID
- NCT05185986
- Acronym / sponsor ID
- 6436
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Executive Functions, Anxiety, Pilates, Cognitive Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Arak University of Medical SciencesUniversity, hospital or other
- Collaborators
- Pardis Specialized Wellness Institute
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 11 Jan 2022 (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.
The main purpose of this study is to evaluate the effectiveness of home-based Pilates exercises and the combination of home-based Pilates exercises with home-based cognitive rehabilitation exercises, also to compare the effects of these two home-based interventions on executive functions and anxiety in MS patients. 51 MS patients of Isfahan MS society will be considered as sample and will be divided randomly into three groups of 17 participants. The first group is home-based Pilates exercises group, the second group is a combination of home-based Pilates exercises and home-based cognitive rehabilitation exercises and the third group is the waiting list group that is considered as the control group. Patients' scores on executive functions and anxiety will be assessed before and after 8 weeks of intervention.
Detailed description
Since the onset of pandemic conditions in 2020 and the increase of lockdowns, almost all rehabilitation programs for MS patients in Iran were suspended, it is necessary to study the effects of home-based cognitive and physical interventions to improve executive functions and anxiety in MS patients. The present study will be conducted to investigate the effects of home-based Pilates exercises and the combination of home-based Pilates exercises with home-based cognitive rehabilitation as well as to compare the effects of these two interventions on executive functions and anxiety in MS patients. In this study, participants will be divided into two experimental groups and a control group. The research process and the reason for conducting the research will be explained to the candidates by lead researcher and the final participants will sign the research participation form. All 51 final participants will be identified by a code and their identity information will not be disclosed, and in order to avoid any bias, each code will be randomly divided into three groups randomly. Pre-test will be taken from all three groups before the intervention. Experiment group 1 will perform a home-based Pilates video training program for 8 weeks, two sessions a week at home, and will also pay attention to exercise-related tips for MS patients determined by specialists. At the same time, Experiment group 2 will be asked to perform home-based cognitive rehabilitation program for 8 weeks, 3 seasons a week at home, in addition to home-based Pilates exercises same as experimental group 1. Group 3 will also be on the waiting list as a control group and will not receive any interventions for 8 weeks. At the end of 8 week intervention, Pilates training packages and cognitive exercises will be provided to the control group for their own use. During the 8 weeks of the intervention, the Pilates instructor and the cognitive rehabilitation specialist will contact the subjects on a weekly basis and monitor their performance. Subjects will also be able to contact the researchers and express their questions and problems. Also, they will be able to hold online meetings with research facilitators for solving the problems and educating the exercises. During the 8 weeks of the intervention, if subjects have problems such as COVID-19 affection, coronary heart disease, muscle problems, relapse, and failure to perform more than 4 sessions of exercise, they will be excluded from the study by the lead researcher. In order to fully perform the exercises for people who do not perform up to 4 sessions of exercises, 2 weeks can be added to the intervention period, which will be applied by the lead researcher. After complete implementation of the intervention, post-test will be taken from all 3 groups and the results will be compared to the baseline and relative to each other.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Home based Pilates exercises | Experimental | Behavioral: Home-Based Pilates exerciseThis group will perform two weekly sessions of Pilates for eight weeks, completed with at least 48-hours between sessions, in their own home, supported by a DVD developed and previously implemented and evaluated by the lead researcher in a feasibility trial among people with Multiple Sclerosis. Each Pilates session will last approximately one hour and is comprised of seven Pilates warm-up exercises and fourteen mat-based beginner's level exercise. Four repetitions of each Pilates movement will be performed during sessions in the first two weeks, with intensity being self-regulated by the participant based on level of physical condition. Repetitions will gradually progress at biweekly intervals, resulting in ten repetitions being performed for the final two weeks of the trial (Weeks 7 and 8). Six post-training stretches will be maintained for a minimum of thirty seconds. |
| Combination of Home-based Pilates exercises and Home-based Cognitive Rehabilitation exercises | Experimental | Behavioral: Home-Based Pilates exercise, Other: Home-based Cognitive RehabilitationIn addition to performing home-based Pilates exercises described in arm 1, this group will also perform home-based cognitive rehabilitation exercises for 8 weeks and 3 sessions per week. The interval between each session is at least 48 hours and each session will take between 30 to 45 minutes. Cognitive rehabilitation exercises are in pen and paper and each session includes two exercises in the areas of planning, cognitive organization, cognitive flexibility and working memory. All exercises will be explained to the subjects by a cognitive rehabilitation specialist, and in addition, explanations of all the exercises in each session will be available for participants in the separate voices. During the intervention period, in addition to the Pilates specialist, the cognitive rehabilitation specialist contacts the group 2 participants on a weekly basis and monitors their rehabilitation exercises. |
| Waiting list group | Other | Other: waiting list groupThis group is the waiting list group and acts as a control group and will be instructed to maintain their preintervention physical and cognitive activity levels during the intervention. After 8 weeks of intervention, Pilates exercises and cognitive rehabilitation exercises will be provided to the participants of this group for their own use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- physician-diagnosed Multiple Sclerosis
- EDSS score < 5
- Free from any other significant physical or psychiatric condition
- Have no previous Pilates experience
Key exclusion criteria (2 listed)
- having cognitive or physical exercises at least from 3 months before intervention.
- Using psychiatric drugs or being under psychotherapy.
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 |
|---|---|---|
| Home-Based Pilates exerciseThe Home-based Pilates is the two Pilates classes at home, twice weekly, for a period of eight weeks. | Behavioural | Combination of Home-based Pilates exercises and Home-based Cognitive Rehabilitation exercises, Home based Pilates exercises |
| Home-based Cognitive RehabilitationHome-based Cognitive Rehabilitation is the 3 sessions per week and 8 weeks of cognitive rehabilitation exercises at home. Each session consists of two Pen and paper exercises. Exercises are active in the areas of planning, cognitive organization, cognitive flexibility and working memory. Each session will take 30 to 45 minutes. | Other | Combination of Home-based Pilates exercises and Home-based Cognitive Rehabilitation exercises |
| waiting list groupThis group act as the control group and will maintain their physical and cognitive activities as the preintervention. Following the 8 weeks of intervention the home-based pilates and cognitive rehabilitation exercises will be provided to them for their own use. | Other | Waiting list group |
Primary outcome
change from baseline total number of cWMI
Time frame: Baseline, week 8
Computerized Working Memory Index (cWMI) The computerized figures width subscale of the Wechsler IQ scale, is used to measure working memory. Figures Width is the working memory subscale of the fourth edition of the Wechsler Intelligence Scale, which consists of two parts: Forward Figures Width and Inverted Figures Width and The sum of a person's scores in these two parts constitutes the total score of the person in this subscale.
change from baseline total time of cTOL
Time frame: Baseline, week 8
Computerized Tower Of London Task (cTOL) a computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards. Each baseline and 8 week set of 12 problems consists of the same number of 2, 3, 4 or 5 move problems and has the same average difficulty level. Every problem could be repeated 3 times to be solved by participants. The dependent variables are the total number of task and the total time spent solving the problem (less time is better) and the delayed time or time to first move (less time is better).
change from baseline score of BAI
Time frame: Baseline, week 8
Beck Anxiety Inventory (BAI) Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".
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 15 Mar 2022.
- Multiple SclerosisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participants' identities will not be shared. Each participant is identified by a code and the data obtained from the assessment of the participants by the research tools and the demographic data of the participants including age, education, marital status and EDSS score will be available via the email of the principal researcher.
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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.
Tooraj Sepahvand, Phd. study director
University of Arak
Mohammad Ali Tabibi, Phd. study chair
Islamic Azad University of Khorasgan
Masoud Etemadifar, Phd. study chair
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Pilates exercise, Home-based Cognitive Rehabilitation and waiting list group in people with Multiple Sclerosis, run by Arak University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 2 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 15 Mar 2022. 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 Iran. 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?
change from baseline total number of cWMI (time frame: Baseline, week 8). The study lists 3 primary outcomes in all. 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 15 Mar 2022.