NCT05716074

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

January 29, 2023

Last Update Submit

January 29, 2023

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosisbalancefatiguequality of life

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Post-intervention (7th week)

Secondary Outcomes (6)

  • Berg Balance Scale (BBS)

    Baseline, (one week before intervention)

  • Berg Balance Scale (BBS)

    Post-intervention (7th week)

  • Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)

    Baseline, (one week before intervention)

  • Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)

    Post-intervention (7th week)

  • ALS Functional Rating Scale Revised (ALSFRS-R)

    Baseline, (one week before intervention)

  • +1 more secondary outcomes

Study Arms (2)

Supervised-exercise group

EXPERIMENTAL

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

Other: Supervised exercise

Home-exercise group

EXPERIMENTAL

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

Other: Home exercise

Interventions

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.

Supervised-exercise group
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.

Home-exercise group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakirkoy, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisFatigue

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Professor Ela Tarakci

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Ela Tarakci, PHD

CONTACT

+905422175730etarakci@iuc.edu.tr

Xhennet Muriqi

CONTACT

+905314856657xhennet.muriqi@ogr.iuc.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 8, 2023

Study Start

November 15, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-01

Locations

TU(1)