Clinical trial NCT06162104: Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome
Official title: Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome: A Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polio and Post-polio Syndrome
Fatigue
Polio
Keywords: Poliomyelitis
Fatigue
Postpoliomyelitis Syndrome
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Individuals aged between 18 and 60 with post-polio syndrome.
* Healthy volunteers aged between 18 and 60

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: 0 day
Secondary outcomes:
measure: Short Form-36
timeFrame: 0 day
measure: Hospital Anxiety and Depression Scale
timeFrame: 0 day
measure: Visual Analogue Scale
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
state: Bahcelievler
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
state: Beylikdüzü
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.