Back to resultsTelerehabilitation vs Supervised Exercises in MS
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Structured Supervised Exercise
Structured telerehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Telerehabilitation, Supervised exercises, Structured exercise, Quality of Life, Activities of Daily Living
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- Istanbul University-Cerrahpaşa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Supervised Exercise Group
Telerehabilitation Group
Arm Description
One session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist.
One session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation
Outcomes
Primary Outcome Measures
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.
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04413682
First Posted
May 30, 2020
Last Updated
May 30, 2020
Sponsor
Istanbul University
Collaborators
Istanbul University - Cerrahpasa (IUC), Medipol University
1. Study Identification
Unique Protocol Identification Number
NCT04413682
Brief Title
Telerehabilitation vs Supervised Exercises in MS
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Istanbul University - Cerrahpasa (IUC), Medipol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Telerehabilitation, Supervised exercises, Structured exercise, Quality of Life, Activities of Daily Living
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will randomly assign to the structured supervised exercise or structured home-based groups. Randomization are done using Microsoft Excel 'RAND()' function.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised Exercise Group
Arm Type
Experimental
Arm Description
One session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist.
Arm Title
Telerehabilitation Group
Arm Type
Experimental
Arm Description
One session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Structured Supervised Exercise
Intervention Description
Structured Exercise Program under the supervision of Physical Therapist
Intervention Type
Behavioral
Intervention Name(s)
Structured telerehabilitation
Intervention Description
Structured Exercise Program checked and controlled through telerehabilitation
Primary Outcome Measure Information:
Title
Functional Independence Measure (FIM)
Description
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.
Time Frame
Changes after 12 weeks
Title
Nottingham Health Profile, First section (NHP-I)
Description
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.
Time Frame
Changes after 12 weeks
Title
Quality of life scale (QoLS)
Description
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).
Time Frame
Changes after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ela Tarakci, Professor
Organizational Affiliation
etarakci@istanbul.edu.tr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpaşa
City
Istanbul
ZIP/Postal Code
34815
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Telerehabilitation vs Supervised Exercises in MS
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