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

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:

NCT05716074

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.

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