Amyotrophic Lateral SclerosisNCT05716074
The Effect of Low-İntensity Combined Exercises in Patients With Early Stage ALS.
A study testing Supervised exercise and Home exercise in people with Amyotrophic Lateral Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Supervised exercise and Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul, Bakirkoy, 34000
Prof Ela Tarakci, +905422175730, etarakci@iuc.edu.tr
Xhennet Muriqi, +905314856657, xhennet.muriqi@ogr.iuc.edu.tr
About this study
Official title: The Effect of Low-İntensity Combined Exercises on Fatigue, Balance and Quality of Life in Patients With Early Stage ALS
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Supervised exercise, Home exercise
- Keywords
- Amyotrophic lateral sclerosis, balance, fatigue, quality of life
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exerciseOther
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.
Home exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised-exercise group | Experimental | This group will be given combined low-intensity exercises under the supervision of a physiotherapist. Receives: Other: Supervised exercise |
| Home-exercise group | Experimental | This group will exercise at home without the supervision of a physiotherapist. Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, (one week before intervention)
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.
Measured: Post-intervention (7th week)
Secondary outcomes (6)
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.
Measured: Baseline, (one week before intervention)
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.
Measured: Post-intervention (7th week)
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.
Measured: Baseline, (one week before intervention)
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.
Measured: Post-intervention (7th week)
ALS Functional Rating Scale Revised (ALSFRS-R)
ALSFRS-R measures activities of daily living (ADL) and global function for patients with Amyotrophic Lateral Sclerosis.
Measured: Baseline, (one week before intervention)
ALS Functional Rating Scale Revised (ALSFRS-R)
ALSFRS-R measures activities of daily living (ADL) and global function for patients with Amyotrophic Lateral Sclerosis.
Measured: Post-intervention (7th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Nov 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xhennet Muriqi, Istanbul University - Cerrahpasa
- Investigators
- Professor Ela Tarakci, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716074
- Sponsor's protocol ID
- E-74555795-050.01.04-531483
- Status last verified
- Jan 2023
- First submitted
- 29 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-İntensity Combined Exercises on Fatigue, Balance and Quality of Life in Patients With Early Stage ALS
- ClinicalTrials.gov ID
- NCT05716074
- Acronym / sponsor ID
- E-74555795-050.01.04-531483
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis, balance, fatigue, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised-exercise group | Experimental | Other: Supervised exerciseThis group will be given combined low-intensity exercises under the supervision of a physiotherapist. |
| Home-exercise group | Experimental | Other: Home exerciseThis group will exercise at home without the supervision of a physiotherapist. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- History of other neurological disease
- Inability to walk
- With mechanical ventilation
- People with Heart and Respiratory Insufficiency
- People with neuropsychological or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exerciseThe 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. | Other | Supervised-exercise group |
| Home exerciseThe 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. | Other | Home-exercise group |
Primary outcome
The fatigue severity scale (FSS)
Time frame: 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.
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.
6 secondary outcomes
Berg Balance Scale (BBS)
Time frame: Baseline, (one week before intervention)
Berg Balance Scale (BBS)
Time frame: Post-intervention (7th week)
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
Time frame: Baseline, (one week before intervention)
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
Time frame: Post-intervention (7th week)
ALS Functional Rating Scale Revised (ALSFRS-R)
Time frame: Baseline, (one week before intervention)
ALS Functional Rating Scale Revised (ALSFRS-R)
Time frame: Post-intervention (7th week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Ela Tarakci principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise and Home exercise in people with Amyotrophic Lateral Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Professor Ela Tarakci, PHD (+905422175730, etarakci@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fatigue severity scale (FSS) (time frame: Baseline, (one week before intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.