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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04413682
Enrollment
30
Registered
2020-06-04
Start date
2019-02-01
Completion date
2020-05-30
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Telerehabilitation, Supervised exercises, Structured exercise, Quality of Life, Activities of Daily Living

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.

Interventions

BEHAVIORALStructured Supervised Exercise

Structured Exercise Program under the supervision of Physical Therapist

BEHAVIORALStructured telerehabilitation

Structured Exercise Program checked and controlled through telerehabilitation

Sponsors

Istanbul University - Cerrahpasa
CollaboratorOTHER
Medipol University
CollaboratorOTHER
Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will randomly assign to the structured supervised exercise or structured home-based groups. Randomization are done using Microsoft Excel 'RAND()' function.

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

patients with: 1. Stable period at the time of application to the clinic 2. Expanded Disability Status Scale Levels between 2 - 6.5 3. Appropriate cognitive level to understand the exercises 4. No diseases to affect their participation in exercise programs

Exclusion criteria

patients with: 1. Poorly controlled diabetes, hypertension or other medical conditions to be incompatible with study participation, 2. A new history of previous attacks 3. No reliable informed consent

Design outcomes

Primary

MeasureTime frameDescription
Functional Independence Measure (FIM)Changes after 12 weeksFIM 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)Changes after 12 weeksNHP 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)Changes after 12 weeksQoLS 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026