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

Completed

• Conditions: Polio and Post-polio Syndrome; Fatigue; Polio
• Interventions: Other: No intervention

• Registration Number: NCT06162104
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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).

Study Timeline

• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Study Start: 2023-12-01
• Study First Posted: 2023-12-08
• Primary Completion: 2023-12-18
• Study Completion: 2023-12-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-poliomyelitis syndrome group	No intervention	Patients suffering from post-poliomyelitis syndrome
Healthy volunteers	No intervention	Control gruoup with healthy volunteers

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	0 day	This scale consists of 9 items assessing the severity of fatigue and its impact on individuals. Each item is scored on a scale ranging from 0 to 7.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale	0 day	The Visual Analog Scale is a simple measurement tool consisting of a line with endpoints representing extreme points of a characteristic, such as "No Pain" to "Worst Pain Imaginable." Respondents mark a point on the line to indicate their perception or experience of the given characteristic.
Hospital Anxiety and Depression Scale	0 day	This scale is a 14-item assessment method, consisting of 7 questions each, designed to inquire about symptoms related to anxiety and depression in patients. As the score increases, the level of anxiety and depression worsens.
Short Form-36	0 day	This form comprises 36 items that inquire about the quality of life. Lower scores indicate a poorer condition.

Trial Locations

Locations (2)

Beylikdüzü State Hospital; 🇹🇷 Istanbul, Beylikdüzü, Turkey

İstanbul Physical Medicine and Rehabilitation Research and Training Hospital; 🇹🇷 Istanbul, Bahcelievler, Turkey