Multiple SclerosisNCT04413682
Telerehabilitation vs Supervised Exercises in MS
A study testing Structured Supervised Exercise and Structured telerehabilitation in people with Multiple Sclerosis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a safe and effective rehabilitation tool for PwMS. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Structured Supervised Exercise and Structured telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 30 May 2020
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with:
- Stable period at the time of application to the clinic
- Expanded Disability Status Scale Levels between 2 - 6.5
- Appropriate cognitive level to understand the exercises
- No diseases to affect their participation in exercise programs
Who cannot join
- patients with:
- Poorly controlled diabetes, hypertension or other medical conditions to be incompatible with study participation,
- A new history of previous attacks
- No reliable informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa
Istanbul, 34815
About this study
Official title: Effectiveness of Structured Exercise Program on Quality of Life and Activities of Daily Living in Persons With Multiple Sclerosis: Telerehabilitation vs Supervised Program
Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a safe and effective rehabilitation tool for PwMS. A structured and personalized exercise program can improve physical fitness, functional capacity, quality of life and modifiable disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation method in PwMS. The purpose of this study is to investigate the effectiveness of exercise programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised exercise and home-based exercise programs for the PwMS.
Read the detailed description
Participants are randomly assigned to the structured supervised exercise or structured home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a week over a 12-weeks structured exercise program under the supervision of a physical therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked and controlled through telerehabilitation three times a week. All measurements pre-post intervention.
- Conditions
- Multiple Sclerosis
- Being tested
- Structured Supervised Exercise, Structured telerehabilitation
- Keywords
- Multiple Sclerosis, Telerehabilitation, Supervised exercises, Structured exercise, Quality of Life, Activities of Daily Living
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Supervised ExerciseBehavioural
Structured Exercise Program under the supervision of Physical Therapist
Structured telerehabilitationBehavioural
Structured Exercise Program checked and controlled through telerehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Group | Experimental | One session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist. Receives: Behavioral: Structured Supervised Exercise |
| Telerehabilitation Group | Experimental | One session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation Receives: Behavioral: Structured telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM)
FIM is a tool used for evaluation of primary ADL of people with disability. FIM items include self care, sphincter control, transfers, locomotion, communication, and social cognition subgroups. Grading is based on 7 points. 7: complete independence, 6: modified independence, 5, 4 and 3: modified dependence, 2 and 1: complete dependence.
Measured: Changes after 12 weeks
Nottingham Health Profile, First section (NHP-I)
NHP is a tool used for measuring and definition of QoL regarding the health status in general. NHP-I contains 38 yes/no statements, focusing on different aspects of the general health problems, including six dimensions of subjective health defined as physical abilities, pain, sleep, energy, emotional reaction, energy level and social isolation. Questions are evaluated according to the patients' yes/no responses and are scored between 0 and 100. High scores indicate high level health status in the specified item. Total scores are summed in all fields.
Measured: Changes after 12 weeks
Quality of life scale (QoLS)
QoLS is a standardized interview consisting of 41 questions clustered in four subscales: functional and economic scale, social and recreational scale, affect and life in general scale, and medical problems scale. Each question in the scale is evaluated over 5 points. (1 is negative at all times and 5 is the best response).
Measured: Changes after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Feb 2019
- Primary completion10 Feb 2020
- Study completion30 May 2020
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.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Medipol University
- Responsible party
- Principal investigator, Ela Tarakci, Istanbul University - Cerrahpasa
- Investigators
- Ela Tarakci, Professor, Principal investigator, etarakci@istanbul.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413682
- Sponsor's protocol ID
- MS-TeleRehab2019
- Status last verified
- May 2020
- First submitted
- 30 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Structured Exercise Program on Quality of Life and Activities of Daily Living in Persons With Multiple Sclerosis: Telerehabilitation vs Supervised Program
- ClinicalTrials.gov ID
- NCT04413682
- Acronym / sponsor ID
- MS-TeleRehab2019
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Telerehabilitation, Supervised exercises, Structured exercise, Quality of Life, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Medipol University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 4 Jun 2020 (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.
Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a safe and effective rehabilitation tool for PwMS. A structured and personalized exercise program can improve physical fitness, functional capacity, quality of life and modifiable disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation method in PwMS. The purpose of this study is to investigate the effectiveness of exercise programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised exercise and home-based exercise programs for the PwMS.
Detailed description
Participants are randomly assigned to the structured supervised exercise or structured home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a week over a 12-weeks structured exercise program under the supervision of a physical therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked and controlled through telerehabilitation three times a week. All measurements pre-post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Group | Experimental | Behavioral: Structured Supervised ExerciseOne session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist. |
| Telerehabilitation Group | Experimental | Behavioral: Structured telerehabilitationOne session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Stable period at the time of application to the clinic
- Expanded Disability Status Scale Levels between 2 - 6.5
- Appropriate cognitive level to understand the exercises
- No diseases to affect their participation in exercise programs
Key exclusion criteria (4 listed)
- Poorly controlled diabetes, hypertension or other medical conditions to be incompatible with study participation,
- A new history of previous attacks
- No reliable 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 |
|---|---|---|
| Structured Supervised ExerciseStructured Exercise Program under the supervision of Physical Therapist | Behavioural | Supervised Exercise Group |
| Structured telerehabilitationStructured Exercise Program checked and controlled through telerehabilitation | Behavioural | Telerehabilitation Group |
Primary outcome
Functional Independence Measure (FIM)
Time frame: Changes after 12 weeks
FIM is a tool used for evaluation of primary ADL of people with disability. FIM items include self care, sphincter control, transfers, locomotion, communication, and social cognition subgroups. Grading is based on 7 points. 7: complete independence, 6: modified independence, 5, 4 and 3: modified dependence, 2 and 1: complete dependence.
Nottingham Health Profile, First section (NHP-I)
Time frame: Changes after 12 weeks
NHP is a tool used for measuring and definition of QoL regarding the health status in general. NHP-I contains 38 yes/no statements, focusing on different aspects of the general health problems, including six dimensions of subjective health defined as physical abilities, pain, sleep, energy, emotional reaction, energy level and social isolation. Questions are evaluated according to the patients' yes/no responses and are scored between 0 and 100. High scores indicate high level health status in the specified item. Total scores are summed in all fields.
Quality of life scale (QoLS)
Time frame: Changes after 12 weeks
QoLS is a standardized interview consisting of 41 questions clustered in four subscales: functional and economic scale, social and recreational scale, affect and life in general scale, and medical problems scale. Each question in the scale is evaluated over 5 points. (1 is negative at all times and 5 is the best response).
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 4 Jun 2020.
- 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.
Ela Tarakci, Professor principal investigator
etarakci@istanbul.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Supervised Exercise and Structured telerehabilitation in people with Multiple Sclerosis, run by Istanbul University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 4 Jun 2020. 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 Turkey (Türkiye). 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?
Functional Independence Measure (FIM) (time frame: Changes after 12 weeks). 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 4 Jun 2020.