ClinicalTrials.gg
CompletedNCT06162104Updated Feb 20, 2024

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

An observational study in Polio and Post-polio Syndrome, Fatigue and Polio, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Completed at 2 sites in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Polio and Post-polio Syndrome
  • Fatigue
  • Polio

Keywords

  • Poliomyelitis
  • Fatigue
  • Postpoliomyelitis Syndrome
03

In context

Postpoliomyelitis Syndrome

28 studies on the registry are indexed under Postpoliomyelitis Syndrome; 3 are open to participants now.

Browse Postpoliomyelitis Syndrome studies →

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 123 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40 participants (actual)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • Post-poliomyelitis syndrome group

    Patients suffering from post-poliomyelitis syndrome

    Other: No intervention

  • Healthy volunteers

    Control gruoup with healthy volunteers

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0 day

Secondary outcomes

  1. Short Form-36

    This form comprises 36 items that inquire about the quality of life. Lower scores indicate a poorer condition.

    Time frame: 0 day

  2. 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.

    Time frame: 0 day

  3. 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.

    Time frame: 0 day

07

Study locations

2 sites
  • İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
    Istanbul, Bahcelievler 34147, Turkey
  • Beylikdüzü State Hospital
    Istanbul, Beylikdüzü 34147, Turkey
08

References and documents

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. PubMed 32790481 ↗
  • 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. PubMed 16931464 ↗
  • 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. PubMed 9790485 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2023 to primary completion in Dec 2023, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2023
First posted
Dec 8, 2023
StartActual
Dec 1, 2023
Primary completionActual
Dec 18, 2023
CompletionActual
Dec 19, 2023
Last update
Feb 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06162104
Responsible party
Sponsor
First posted
Dec 8, 2023
Start date
Dec 1, 2023
Primary completion
Dec 18, 2023
Completion
Dec 19, 2023
Last update
Feb 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion