UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053947 |
|---|---|
| Receipt number | R000061575 |
| Scientific Title | Comparative effects of dual-task training versus combined exercise training in water and on land on patients with multiple sclerosis: A Study protocol of a randomized factorial trial |
| Date of disclosure of the study information | 2024/03/22 |
| Last modified on | 2024/08/02 17:01:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparative effects of dual-task training versus combined exercise training in water and on land on cognition, balance, and gait of patients with multiple sclerosis: A Study protocol of a randomized factorial trial
Acronym
the effects of dual-task training versus combined exercise training in water and on land on cognition, balance, and gait of patients with multiple sclerosis.
Scientific Title
Comparative effects of dual-task training versus combined exercise training in water and on land on patients with multiple sclerosis: A Study protocol of a randomized factorial trial
Scientific Title:Acronym
the effects of dual-task training versus combined exercise training in water and on land on patients with multiple sclerosis.
Region
| Asia(except Japan) |
Condition
Condition
exercise therapy pre-post intervention of patients with multiple sclerosis
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
is to compare the effects of DTT and combined exercise training in water-based and land-based environments on Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) in PwMS over a 12-weeks and to examine the effects of these treatments interact with each other.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Symbol Digit Modalities Test (SDMT) in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS).
Key secondary outcomes
The California Verbal Learning Test (CVLT) and The Brief Visuospatial Memory Test (BVMTR) in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS).
kinetics and kinematics throughout the balance and gait cycle, encompassing spatiotemporal parameters, sagittal plane angles, and moments of the hip, knee, and ankle, as well as anteroposterior, mediolateral, and vertical ground reaction forces.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group: dual-task training in water.
Interventions/Control_2
Intervention group: dual task training on land.
Interventions/Control_3
Intervention group: combined exercise training in water.
Interventions/Control_4
Intervention group: combined exercise training on land.
Interventions/Control_5
Control group: cycling in water.
Interventions/Control_6
Control group: cycling on land.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with relapsing-remitting MS as outlined by the McDonald criteria,
The EDSS between 1.0 and 5.5,
Relapse-free for the last 3 months,
lack of regular physical exercise,(no training within the last three months),
willingness to participate in the current study,
Cognitive impairments that will be characterized by scores below the standard criterion at least 1.5 standard deviations from the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS).
Key exclusion criteria
Unable to comply with the requirements of the protocol
Inability to stand and walk without aids and braces
Changes in medication in past 2 months,
History of cardiovascular, kidney, or other chronic diseases, Pregnancy in past 12 months,
medical conditions interfering with mobility, MS-like syndromes such as neuromyelitis optica, or major problems with hearing, vision, and perception.
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Seyed Sadredin |
| Middle name | |
| Last name | Shojaedin |
Organization
Kharazmi University
Division name
Sport medicine
Zip code
15719-14911
Address
No.43 South Mofateh St Tehran
TEL
+989125073897
sa_shojaedin@yahoo.com
Public contact
Name of contact person
| 1st name | sahar |
| Middle name | |
| Last name | nazary soltan ahmad |
Organization
kharazmi university
Division name
sport medicine
Zip code
15719-14911
Address
No.43 South Mofateh St Tehran
TEL
+989106740486
Homepage URL
saharnazary1992@gmail.com
Sponsor or person
Institute
Kharazmi university
Institute
Department
Personal name
Funding Source
Organization
Kharazmi university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sport Sciences Research Institute (SSRI)
Address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran
Tel
+982188747884
ssrc.intoffice@ssrc.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
228
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2024 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061575
