Skip to content

The Effect of Low-İntensity Combined Exercises in Patients With Early Stage ALS.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05716074
Enrollment
30
Registered
2023-02-08
Start date
2022-11-15
Completion date
2023-06-30
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis, balance, fatigue, quality of life

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.

Interventions

OTHERSupervised exercise

The supervised group will be given 10 minutes of warm-up, 10 minutes of breathing exercises, 20 minutes of low endurance combined exercises (stretching, strengthening, strength exercises), 10 minutes of balance and walking training, and 10 minutes of cool-down exercises. Exercise will be applied for 1 hour a day, 3 days a week for 6 weeks.

OTHERHome exercise

The home group will be given 10 minutes of warm-up, 10 minutes of breathing exercises, 20 minutes of low endurance combined exercises (stretching, strengthening, strength exercises), 10 minutes of balance and walking training, and 10 minutes of cool-down exercises. Exercise will be applied for 1 hour a day, 3 days a week for 6 weeks in the home.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The fatigue severity scale (FSS)Baseline, (one week before intervention)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

MeasureTime frameDescription
Berg Balance Scale (BBS)Baseline, (one week before intervention)The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)Baseline, (one week before intervention)The ALSAQ-40 provides scores for 5 scales: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional reactions.
ALS Functional Rating Scale Revised (ALSFRS-R)Baseline, (one week before intervention)ALSFRS-R measures activities of daily living (ADL) and global function for patients with Amyotrophic Lateral Sclerosis.

Countries

Turkey (Türkiye)

Contacts

Primary ContactProfessor Ela Tarakci, PHD
etarakci@iuc.edu.tr+905422175730
Backup ContactXhennet Muriqi
xhennet.muriqi@ogr.iuc.edu.tr+905314856657

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026