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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supervised exercise
Home exercise
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic lateral sclerosis, balance, fatigue, quality of life

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Supervised-exercise group

Home-exercise group

Arm Description

This group will be given combined low-intensity exercises under the supervision of a physiotherapist.

This group will exercise at home without the supervision of a physiotherapist.

Outcomes

Primary Outcome Measures

The fatigue severity scale (FSS)
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.
The fatigue severity scale (FSS)
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 Outcome Measures

Berg Balance Scale (BBS)
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.
Berg Balance Scale (BBS)
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)
The ALSAQ-40 provides scores for 5 scales: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional reactions.
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
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)
ALSFRS-R measures activities of daily living (ADL) and global function for patients with Amyotrophic Lateral Sclerosis.
ALS Functional Rating Scale Revised (ALSFRS-R)
ALSFRS-R measures activities of daily living (ADL) and global function for patients with Amyotrophic Lateral Sclerosis.

Full Information

First Posted
January 29, 2023
Last Updated
January 29, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05716074
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic lateral sclerosis, balance, fatigue, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supervised-exercise group
Arm Type
Experimental
Arm Description
This group will be given combined low-intensity exercises under the supervision of a physiotherapist.
Arm Title
Home-exercise group
Arm Type
Experimental
Arm Description
This group will exercise at home without the supervision of a physiotherapist.
Intervention Type
Other
Intervention Name(s)
Supervised exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
The fatigue severity scale (FSS)
Description
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.
Time Frame
Baseline, (one week before intervention)
Title
The fatigue severity scale (FSS)
Description
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.
Time Frame
Post-intervention (7th week)
Secondary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
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.
Time Frame
Baseline, (one week before intervention)
Title
Berg Balance Scale (BBS)
Description
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.
Time Frame
Post-intervention (7th week)
Title
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
Description
The ALSAQ-40 provides scores for 5 scales: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional reactions.
Time Frame
Baseline, (one week before intervention)
Title
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
Description
The ALSAQ-40 provides scores for 5 scales: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional reactions.
Time Frame
Post-intervention (7th week)
Title
ALS Functional Rating Scale Revised (ALSFRS-R)
Description
ALSFRS-R measures activities of daily living (ADL) and global function for patients with Amyotrophic Lateral Sclerosis.
Time Frame
Baseline, (one week before intervention)
Title
ALS Functional Rating Scale Revised (ALSFRS-R)
Description
ALSFRS-R measures activities of daily living (ADL) and global function for patients with Amyotrophic Lateral Sclerosis.
Time Frame
Post-intervention (7th week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Ela Tarakci, PHD
Phone
+905422175730
Email
etarakci@iuc.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Xhennet Muriqi
Phone
+905314856657
Email
xhennet.muriqi@ogr.iuc.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Ela Tarakci
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Ela Tarakci
Phone
+905422175730
Email
etarakci@iuc.edu.tr
First Name & Middle Initial & Last Name & Degree
Xhennet Muriqi
Phone
+905314856657
Email
xhennet.muriqi@ogr.iuc.edu.tr

12. IPD Sharing Statement

Learn more about this trial

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

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