Telerehabilitation vs Supervised Exercises in MS
Effectiveness of Structured Exercise Program on Quality of Life and Activities of Daily Living in Persons With Multiple Sclerosis: Telerehabilitation vs Supervised Program
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2020
CompletedFirst Submitted
Initial submission to the registry
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedJune 4, 2020
May 1, 2020
1 year
May 30, 2020
May 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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).
Changes after 12 weeks
Study Arms (2)
Supervised Exercise Group
EXPERIMENTALOne session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist.
Telerehabilitation Group
EXPERIMENTALOne session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation
Interventions
Structured Exercise Program under the supervision of Physical Therapist
Structured Exercise Program checked and controlled through telerehabilitation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istanbul Universitylead
- Istanbul University - Cerrahpasacollaborator
- Medipol Universitycollaborator
Study Sites (1)
Istanbul University-Cerrahpaşa
Istanbul, 34815, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ela Tarakci, Professor
etarakci@istanbul.edu.tr
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will randomly assign to the structured supervised exercise or structured home-based groups. Randomization are done using Microsoft Excel 'RAND()' function.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 30, 2020
First Posted
June 4, 2020
Study Start
February 1, 2019
Primary Completion
February 10, 2020
Study Completion
May 30, 2020
Last Updated
June 4, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share