Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome

NCT ID: NCT06162104

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2023-12-19

Brief Summary

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The aim of this study is to investigate the differences in the severity of fatigue, impact on quality of life, and mood between individuals with post-polio syndrome and healthy volunteer groups. Additionally, the interrelationships of these parameters within the post-polio syndrome patient group will be examined. The goal is to raise awareness during the follow-up process for individuals with post-polio syndrome by questioning fatigue and mood symptoms, and to facilitate the implementation of necessary precautions.

Detailed Description

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Our research is designed as a case-control study. 20 patients diagnosed with post-polio syndrome who present to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital clinics and 20 healthy volunteers will be included in the study. The sociodemographic data of patients and volunteers, such as age, gender, height, weight, body mass index, education level, and occupation, will be recorded. The age at which polio was contracted, the time elapsed since polio, and any accompanying illnesses will be documented. Additionally, if patients experience new symptoms such as pain, weakness, or fatigue, the severity of these symptoms will be assessed using the Visual Analog Scale. The frequency of falls and the presence of fractures caused by falls, ambulation method, and devices used will be noted. Muscle weakness in the extremities will be identified by applying the Manual Muscle Test through physical examination. Subsequently, the patient's current symptoms related to depression and anxiety will be evaluated using the Hospital Anxiety and Depression Scale (HADS), fatigue level will be assessed using the Fatigue Severity Scale (FSS), and quality of life will be evaluated using the Short Form-36 (SF-36).

Conditions

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Polio and Post-polio Syndrome Fatigue Polio

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Post-poliomyelitis syndrome group

Patients suffering from post-poliomyelitis syndrome

No intervention

Intervention Type OTHER

No intervention

Healthy volunteers

Control gruoup with healthy volunteers

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals aged between 18 and 60 with post-polio syndrome.
* Healthy volunteers aged between 18 and 60

Exclusion Criteria

* fibromyalgia,
* chronic fatigue syndrome,
* presence of chronic decompensated cardiac, renal, and hepatic insufficiency,
* known psychiatric disorders,
* rheumatological diseases,
* presence of other known neurological diseases,
* use of medications aimed at improving physical performance or alleviating fatigue.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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İstanbul Physical Medicine and Rehabilitation Research and Training Hospital

Istanbul, Bahcelievler, Turkey (Türkiye)

Site Status

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Gusi N, Madruga M, Gonzalez-Gonzalez MLA, Perez-Gomez J, Prieto-Prieto J. Health-related quality of life and multidimensional fitness profile in polio survivors. Disabil Rehabil. 2022 Apr;44(8):1374-1379. doi: 10.1080/09638288.2020.1804629. Epub 2020 Aug 13.

Reference Type BACKGROUND
PMID: 32790481 (View on PubMed)

On AY, Oncu J, Atamaz F, Durmaz B. Impact of post-polio-related fatigue on quality of life. J Rehabil Med. 2006 Sep;38(5):329-32. doi: 10.1080/16501970600722395.

Reference Type BACKGROUND
PMID: 16931464 (View on PubMed)

Bruno RL, Creange SJ, Frick NM. Parallels between post-polio fatigue and chronic fatigue syndrome: a common pathophysiology? Am J Med. 1998 Sep 28;105(3A):66S-73S. doi: 10.1016/s0002-9343(98)00161-2.

Reference Type RESULT
PMID: 9790485 (View on PubMed)

Other Identifiers

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IstPRMTRH6

Identifier Type: -

Identifier Source: org_study_id

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