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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06162104
• Other study ID #: IstPRMTRH6
• Status: Completed
• Start date: December 1, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: February 2024
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 19, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Polio
• Polio and Post-polio Syndrome
• Poliomyelitis
• Postpoliomyelitis Syndrome
• Syndrome

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Turkey	Beylikdüzü State Hospital	Istanbul	Beylikdüzü
Turkey	Istanbul Physical Medicine and Rehabilitation Research and Training Hospital	Istanbul	Bahcelievler

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Short Form-36	This form comprises 36 items that inquire about the quality of life. Lower scores indicate a poorer condition.	0 day
Secondary	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
Secondary	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