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Completed

NCT Number: NCT04413682

Telerehabilitation vs Supervised Exercises in MS

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpaşa

Istanbul, 34815, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Supervised Exercise

Behavioral

Structured Exercise Program under the supervision of Physical Therapist

Structured telerehabilitation

Behavioral

Structured Exercise Program checked and controlled through telerehabilitation

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Istanbul University - Cerrahpasa
  • Medipol University

Registry information

Official study title

Effectiveness of Structured Exercise Program on Quality of Life and Activities of Daily Living in Persons With Multiple Sclerosis: Telerehabilitation vs Supervised Program

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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