Clinical Trials Logo

Clinical Trial Summary

The aim of our study is to investigate the effectiveness of two exercise programs supervised by a physiotherapist, performed in the hospital or at their home via electronic connection in a group of LGMD and SMA patients. One exercise session will consist of breathing, posture, dynamic core stabilization, upper and lower extremity strengthening exercises. The basic exercises from each group will be performed as 1 set of 5 repetitions at the beginning and will be gradually increased according to the tolerability of the patient. Fourteen subjects will be enrolled this randomized controlled study. Demographic characteristics, Vignos scale, Brooke scale, Barthel index, upper extremity functional index, Nottingham Health profile, short form-36, 6 minute walk test and muscle thicknesses measured by ultrasound of certain muscles will be recorded.


Clinical Trial Description

Some neuromuscular diseases with myogenic or neurogenic origin present with proximal muscle weakness. These diseases preferentially affect muscles around shoulders and hips and hence are called limb girdle neuromuscular diseases (LG-NMD). Patients have difficulty in climbing stairs or hills, and reaching high shelves. The vast majority of these diseases are X-linked recessive, autosomal recessive or dominantly inherited muscular dystrophies and are called limb girdle muscular dystrophies (LGMD). Spinal muscular atrophy (SMA), a disease of motor neurons, is also characterized by progressive proximal muscle weakness. Although the diseases are progressive in both conditions, regular and proper doses of exercise starting from the early stages may delay the progression of muscle weakness and may prevent joint stiffness, and contractures. The strengthening and aerobic exercise program increases overall wellness, condition and muscle strength in patients with neuromuscular diseases. The aerobic exercise program under supervision enhances oxidative capacity and muscle function without causing fatigue. Patients performing regular exercise program report an increase in their physical endurance, leg muscle strength and walking distance. Submaximal strengthening exercises combined with aerobic exercise are highly effective. Regulation of the exercise program according to the needs of the patient is the most important step. Appropriate individualized exercises should be programmed by a physical medicine and rehabilitation physician and performed under the supervision of a physiotherapist in the hospital environment in order to be effective. Otherwise, success of rehabilitation and patient compliance might be reduced. With the development of technology, patients can perform exercises at their home under remote supervision by a physiotherapist via electronic connection. Therefore, the aim of our study is to investigate the effectiveness of two exercise programs supervised by a physiotherapist, performed in the hospital or at their home via electronic connection in a group of LGMD and SMA patients. Fourteen consecutive patients from the Koç University Center for Muscle Diseases (KUCMD) diagnosed with LGMD or SMA are enrolled. Patients followed by KUCMD outpatient clinic with proximal muscle weakness who held LGMD or SMA diagnoses will be evaluated by a physical medicine and rehabilitation physician. Demographic characteristics, Vignos scale, Brooke scale, Barthel index, upper extremity functional index, Nottingham Health profile, short form-36, 6 minute walk test and muscle thicknesses measured by ultrasound of certain muscles will be recorded. Patients will be randomized into two groups. The first group will perform the exercises in the hospital under the supervision of a physiotherapist (Group 1: Hospital based rehabilitation group) and the second group will perform the exercises at their home under remote supervision of a physiotherapist via internet connection (Group 2: Telerehabilitation group). The exercise program will be administered 3 times in a week for 10 weeks. Patients will be examined by a blinded neurologist and functional assessments and ultrasonographic evaluations will be performed by a blinded physical medicine and rehabilitation physician before and after the rehabilitation program and at the 6th and 12th months following the completion of the rehabilitation. One exercise session will consist of breathing, posture, dynamic core stabilization, upper and lower extremity strengthening exercises. The basic exercises from each group will be performed as 1 set of 5 repetitions at the beginning and will be gradually increased according to the tolerability of the patient. If the patient has difficulty performing the basic exercises, modifications of the relevant exercise will be applied. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04392518
Study type Interventional
Source Koç University
Contact Ihsan Solaroglu, Prof
Phone + 90 212 338 10 39
Email isolaroglu@ku.edu.tr
Status Recruiting
Phase N/A
Start date September 15, 2019
Completion date November 2021

See also
  Status Clinical Trial Phase
Completed NCT03574480 - Smartphone Applications to Improve Lifestyles in Olders Over 65 Years N/A
Not yet recruiting NCT04070066 - Educational Strategy IN Exchange Transfusion N/A
Recruiting NCT05043220 - Covid-19 Predictors: Safety of Gynecological Oncology Patients Undergoing Systemic Cancer Therapy N/A
Recruiting NCT04045054 - Home-based Transitional Telecare for Older Veterans N/A
Completed NCT04652674 - Impact of Postoperative Telemedicine Visit vs In-person Visit on Patient Satisfaction During the COVID-19 Pandemic N/A
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Recruiting NCT05480930 - Improving Nighttime Access to Care and Treatment; Part 4-Haiti N/A
Completed NCT03025217 - Total Lifestyle Coaching Pilot Study (TLC) N/A
Completed NCT02196428 - Medical Telemonitoring Plus Individual Teleconsultation in Elderly N/A
Completed NCT01820234 - Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event N/A
Completed NCT05147038 - The Impact of Tele-coaching on the Physical Activity Level N/A
Not yet recruiting NCT05897710 - Virtual World-Based Cardiac Rehabilitation N/A
Not yet recruiting NCT04444297 - 3D Telemedicine During COVID-19: Non-clinical Validation N/A
Not yet recruiting NCT04513496 - Telemedicine in HIV Care in Buenos Aires
Completed NCT05895539 - Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool N/A
Active, not recruiting NCT03474692 - Virta Health Registry
Recruiting NCT05046392 - mHealth Facilitated Intervention to Improve Medication Adherence Among Persons Living With HIV N/A
Recruiting NCT05231018 - A Study on a Digital Platform for COVID19+ Patients, Designed to Facilitate Communication and Mental-health Care During and After Hospitalization. N/A
Recruiting NCT05617560 - Hospital@Home: Telemedical Care After Inpatient Hospital Stay N/A
Completed NCT03007745 - Remote Sleep Apnea Management N/A