Daily Living Activities and Exercise Capacity in Lipid Storage Diseases

August 15, 2023 updated by: Goksen Kuran Aslan, Istanbul University

The Investigation of Daily Living Activities and Exercise Capacity in Lipid Storage Diseases

Lipid Storage Diseases (LSD) is a group of metabolic diseases that are manifested by exercise intolerance or muscle weakness, sometimes accompanied by systemic findings, which develop in some stages of muscle contraction due to necessary lipid transfer or destruction pathways. Exercise intolerance in LSD can limit not only physical activity but also daily activities. In the literature, no study evaluated the activities of daily living in patients with LSD. The aim of this study was to investigate the effect of exercise capacity and daily living activities on the clinical features of LSD patients.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Pulmonary functions are affected negatively in Lipid Storage Diseases (LSD). It was shown that respiratory muscle strength and peak cough flow decreased in these cases. Other respiratory system problems can be listed as; diaphragmatic dysfunction, hypoxemia, and hypercapnia. Routine evaluation of respiratory function in LSD is recommended. A limited number of studies have shown that exercise tolerance is limited by the blockage of fat oxidation on the basis of muscle weakness and fatigue in LSD. Although the assessment of exercise capacity is also an important indicator of heart-lung capacity monitoring, exercise capacity is not routinely measured in patients with LSD. Exercise intolerance can limit not only physical activity but also daily activities. In the literature, the investigator's did not find any study evaluating the activities of daily living in patients with LSD. The aim of this study was to investigate the effect of exercise capacity and daily living activities on the clinical features of LSD patients.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Goksen Kuran Aslan, Assoc.Prof
  • Phone Number: 40167 +90 (212) 414 15 28
  • Email: goksenkuran@yahoo.com

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University
        • Contact:
        • Sub-Investigator:
          • Buket Akinci, Assist.Prof.
        • Sub-Investigator:
          • Esen Kiyan, Prof.Dr.
        • Sub-Investigator:
          • Hacer Durmus Tekce, Assoc.Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

25 patients who were diagnosed with Lipid Storage Disease at Istanbul University Istanbul Medical Faculty Neurology and Chest Diseases Departments will be invited to the study. The study will be continued in Istanbul University, Istanbul Faculty of Medicine, Department of Chest Diseases.

Description

Inclusion Criteria:

  • Being diagnosed with Lipid storage disease clinically and histopathologically.

Exclusion Criteria:

  • Severe pulmonary parenchymal disease,
  • Cardiac problems
  • Renal or hepatic dysfunction
  • Uncontrolled hypothyroidism
  • Acute infection
  • Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 minutes walking test
Time Frame: 1 day
Exercise capacity will be evaluated with 6 minutes walking test
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity limitation (ACTIVLIM) questionnaire
Time Frame: 1 day
Activities of daily living will be evaluated Activlim questionnaire. The questionnaire is consists of 22 questions. Minimum score is 0 and total score is 88. Higher scores indicate worse conditions.
1 day
Rivermead mobility index
Time Frame: 1 day
Mobility will be evaluated with Rivermead mobility index. The questionnaire consists of 14 questions. Minimum score is 0, maximum score is 15. Higher scores indicate better conditions.
1 day
Hand held dinamometer
Time Frame: 1 day
Hand held dinamometer will be used for the measurement of upper and lower muscle strength.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Collaborators

Biruni University

Investigators

  • Principal Investigator: Goksen Kuran Aslan, Assoc.Prof., Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 2, 2023

Primary Completion (Estimated)

September 4, 2024

Study Completion (Estimated)

November 5, 2024

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/24-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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