Telerehabilitation vs Supervised Exercises in MS

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413682
• Other study ID #: MS-TeleRehab2019
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: May 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Structured Supervised Exercise
Structured Exercise Program under the supervision of Physical Therapist
• Structured telerehabilitation
Structured Exercise Program checked and controlled through telerehabilitation

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
Istanbul University	Istanbul University-Cerrahpasa, Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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