Study Purpose:
The aim of this study is to investigate the effects of low-intensity combined exercises on balance, fatigue and quality of life applied to patients with ALS.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
Supervised exercise, Home exercise
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Professor Ela Tarakci, Istanbul University - Cerrahpasa (IUC)
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Professor Ela Tarakci, PHD / email hidden; JavaScript is required / +905422175730
Full Study Summary:
Balance problems and signs of fatigue are seen in early-stage ALS patients. While balance problems lead to falls in ALS patients, fatigue also affects a part of their lives. Studies investigating the effects of low-intensity exercise on fatigue, balance, and quality of life in patients with early-stage ALS are rare. This study will investigate the effects of low-intensity combined exercises on balance, fatigue and quality of life in patients with ALS.
Participants will be randomly divided into Supervised and Home groups. Low-intensity exercises will be applied to the home exercise group as a home program for 1 hour a day, 3 days a week, for 6 weeks. Low-intensity exercises will be applied to the supervised exercise group for 1 hour a day, 3 days a week for 6 weeks, accompanied by a physiotherapist. Evaluations will be made at the beginning and at the end of the treatment.
Berg Balance Scale, Fatigue Severity Scale (FSS), Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) and revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) will be used to evaluate patients before and 6 weeks after treatment.
Participants will be randomly divided into Supervised and Home groups. Low-intensity exercises will be applied to the home exercise group as a home program for 1 hour a day, 3 days a week, for 6 weeks. Low-intensity exercises will be applied to the supervised exercise group for 1 hour a day, 3 days a week for 6 weeks, accompanied by a physiotherapist. Evaluations will be made at the beginning and at the end of the treatment.
Berg Balance Scale, Fatigue Severity Scale (FSS), Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) and revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) will be used to evaluate patients before and 6 weeks after treatment.
Study Sponsor:
Istanbul University - Cerrahpasa (IUC)
Estimated Enrollment:
30
Estimated Study Start Date:
11 / 15 / 2022
Estimated Study Completion Date:
06 / 01 / 2023
Posting Last Modified Date:
02 / 08 / 2023
Date Study Added to neals.org:
02 / 08 / 2023
Minimum Age:
30 Years
Maximum Age:
65 Years
Inclusion Criteria:- Being diagnosed with early-stage ALS by a neurologist
- Disease duration in the range of 1-18 months
- ALSFRS-R score > 24 higher
- Without infectious disease
- Saturation >95
- Heart rate <92
Exclusion Criteria:
- History of other neurological disease
- Inability to walk
- With mechanical ventilation
- People with Heart and Respiratory Insufficiency
- People with neuropsychological or cognitive impairment
- Dyspnea after ALS
Istanbul University-Cerrahpasa | Recruiting
Prof Ela Tarakci / +905422175730 / email hidden; JavaScript is required
Xhennet Muriqi / +905314856657 / email hidden; JavaScript is required
Istanbul, Bakirkoy
34000
Turkey