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Clinical Trials/NCT05716074
NCT05716074
Recruiting
Not Applicable

The Effect of Low-İntensity Combined Exercises on Fatigue, Balance and Quality of Life in Patients With Early Stage ALS

Istanbul University - Cerrahpasa (IUC)1 site in 1 country30 target enrollmentNovember 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amyotrophic Lateral Sclerosis
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
30
Locations
1
Primary Endpoint
The fatigue severity scale (FSS)
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2022
End Date
June 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Xhennet Muriqi

Researcher

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

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

Outcomes

Primary Outcomes

The fatigue severity scale (FSS)

Time Frame: Post-intervention (7th week)

FSS is a self-report scale of nine items examining motivation, physical function, responsibilities, work, family or social life, exercise, fatigue, frequency of problems, and priority of symptoms.

Secondary Outcomes

  • Berg Balance Scale (BBS)(Post-intervention (7th week))
  • Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)(Post-intervention (7th week))
  • ALS Functional Rating Scale Revised (ALSFRS-R)(Post-intervention (7th week))

Study Sites (1)

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