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

Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome: A Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Polio; Polio and Post-polio Syndrome
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

• Study Contact: Name: Büşra Şirin Ahısha, MD; Phone Number: 05544480418; Email: bsrn080@gmail.com
• Study Contact Backup: Name: Nurdan Paker; Email: nurdanpaker@hotmail.com

Study Locations

• Turkey
  • Bahcelievler
    • Istanbul, Bahcelievler, Turkey, 34147
      • İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
  • Beylikdüzü
    • Istanbul, Beylikdüzü, Turkey, 34147
      • Beylikdüzü State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-poliomyelitis syndrome group; Patients suffering from post-poliomyelitis syndrome	Other: No intervention; No intervention
Healthy volunteers; Control gruoup with healthy volunteers	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Severity Scale	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.	0 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form-36	This form comprises 36 items that inquire about the quality of life. Lower scores indicate a poorer condition.	0 day
Hospital Anxiety and Depression Scale	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.	0 day
Visual Analogue Scale	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.	0 day

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Fatigue; Poliomyelitis; Postpoliomyelitis Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Central Nervous System Infections; Neurodegenerative Diseases; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Muscular Disorders, Atrophic; Myelitis; Neuroinflammatory Diseases; Syndrome; Fatigue; Poliomyelitis; Postpoliomyelitis Syndrome
• Other Study ID Numbers: IstPRMTRH6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No