Telerehabilitation vs Supervised Exercises in MS

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Structured telerehabilitation; Behavioral: Structured Supervised Exercise

• Registration Number: NCT04413682
• Lead Sponsor: Istanbul University

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-02-10
• Status Verified: 2020-05
• Study Completion: 2020-05-30
• Study First Submitted: 2020-05-30
• Study First Submitted QC: 2020-05-30
• Last Update Submitted: 2020-05-30
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telerehabilitation Group	Structured telerehabilitation	One session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation
Supervised Exercise Group	Structured Supervised Exercise	One session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist.

Primary Outcome Measures

Name	Time	Method
Functional Independence Measure (FIM)	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.
Quality of life scale (QoLS)	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).
Nottingham Health Profile, First section (NHP-I)	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.

Trial Locations

Locations (1)

Istanbul University-Cerrahpaşa; 🇹🇷 Istanbul, Turkey