Clinical trial NCT05716074: The Effect of Low-İntensity Combined Exercises in Patients With Early Stage ALS.
Official title: The Effect of Low-İntensity Combined Exercises on Fatigue, Balance and Quality of Life in Patients With Early Stage ALS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis
balance
fatigue
quality of life
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The fatigue severity scale (FSS)
timeFrame: Baseline, (one week before intervention)
measure: The fatigue severity scale (FSS)
timeFrame: Post-intervention (7th week)
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Baseline, (one week before intervention)
measure: Berg Balance Scale (BBS)
timeFrame: Post-intervention (7th week)
measure: Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
timeFrame: Baseline, (one week before intervention)
measure: Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
timeFrame: Post-intervention (7th week)
measure: ALS Functional Rating Scale Revised (ALSFRS-R)
timeFrame: Baseline, (one week before intervention)
measure: ALS Functional Rating Scale Revised (ALSFRS-R)
timeFrame: Post-intervention (7th week)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakirkoy
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Professor Ela Tarakci
role: PRINCIPAL_INVESTIGATOR
References: