Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Aquatic Exercise in Patients With Knee Osteoarthritis

2. november 2026 oppdatert av: Mensure Aslan, Kirsehir Ahi Evran Universitesi

The Effect of Aquatic Exercise on Central Sensitization and Functional Parameters in Patients With Knee Osteoarthritis: a Randomized Controlled Trial

The effect of aquatic exercise on central sensitization in patients with knee osteoarthritis are not fully known in the studies conducted to date. The aim of this study is to examine the effect of aquatic exercise on central sensitization and functional parameters in patients with knee osteoarthritis.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Merkez
      • Kırşehir, Merkez, Tyrkia (Türkiye), 40000
        • Rekruttering
        • Kirsehir Ahi Evran University, Kırşehir, Merkez 40100
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Adults aged 40-65
  2. Individuals diagnosed with knee osteoarthritis
  3. Individuals with no cognitive impairments
  4. Volunteers for the study

Exclusion Criteria:

  1. Individuals who have undergone knee surgery
  2. Individuals presenting with signs such as fracture, malignancy, or infection
  3. Pregnancy
  4. Individuals with cognitive impairments who are unable to express themselves.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Standard physical group

Participants receive standard physical therapy sessions for knee osteoarthritis for 8 weeks, each session is 60minutes.

Standard physical conventional therapy exercises for knee osteoarthritis.

Eksperimentell: Standard physical group and hydrotherapy

• Participants receive standard physical therapy sessions combined with hydrotherapy (pool therapy) sessions for knee osteoarthritis for 8 weeks, each session is 60 minutes.

Standard physical conventional therapy exercises for knee osteoarthritis.

Hydrotherapy (pool therapy) sessions tailored to standard physiotherapy for knee osteoarthritis.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Central Sensitization
Tidsramme: 8 weeks

The Central Sensitization Inventory is a valid tool for assessing psychological and sensory factors associated with central pain sensitivity in patients with knee osteoarthritis. The Central Sensitization Inventory demonstrates moderate reliability in patients who have developed central sensitization due to knee osteoarthritis. Part A consists of 25 items that assess an individual's symptoms of central sensitization; it is scored using a 4-point Likert scale. Part B assesses whether the patient has received a diagnosis of another condition within the family of central sensitization syndromes from a physician. A high score indicates severe central sensitization.Number of Items: Section A of the scale, which is included in the assessment, consists of 25 items. Item Scoring: Each item uses a 5-point Likert-type scale, ranging from 0 to 4 points (0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always). Minimum Score: 0; Maximum Score: 100

8 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual Analog Scale
Tidsramme: 8 weeks

Participants' pain intensity will be assessed. Pain intensity is indicated on a 10 cm straight line with anchor points representing "no pain" and "worst pain imaginable." The distance between the starting point and the point marked by the patient is measured in centimeters. An increase in this distance signifies an increase in pain intensity. This is an assessment method, ranging from 0 to 10 (or 0-100 mm), used to measure the severity of subjective symptoms-most commonly pain. A score of 0 indicates no pain; 1-3, mild pain; 4-6, moderate pain; 7-9, severe pain; and 10, unbearable, extreme pain.

8 weeks
Knee Injury and Osteoarthritis Outcome Score
Tidsramme: 8 weeks

Knee-related quality of life scales for patients with knee osteoarthritis are tools used to assess pain, function, and activities of daily living. They comprise 42 items across five distinct subscales. A higher total score indicates extremely severe pain in the knee, restricted movement, and loss of function. Scores range from 0 points to 100 points.

8 weeks
Algometer
Tidsramme: 8 weeks

Central sensitization is assessed by measuring the Pressure Pain Threshold (PPT). Pressure will be applied to the quadriceps muscle using an algometer until the patient perceives pain. The procedure will be performed three times at 20-second intervals, and the average value will be calculated. Subsequently, the patient will immerse their foot and ankle in cold water (1-4°C) for 60-120 seconds. Following this, the PPT will be measured again at the same point on the quadriceps muscle using the algometer, and the total score will be calculated. A high score indicates that central sensitization is not present. An algometer is a physical device that provides objective measurements. Consequently, the results obtained from the device are not scores, but rather values expressed in units of applied pressure. A low score, on the other hand, shows that central sensitization is present.

8 weeks
SF-36 Quality of Life Scale (36-Item Short Form Health Survey)
Tidsramme: 8 weeks

It measures an individual's quality of life. The questionnaire consists of 36 items and 8 sub-parameters (physical functioning, bodily pain, limitations due to physical problems, emotional well-being, social functioning, energy/fatigue, and general health perception). A high score on the SF-36 questionnaire indicates that the patient's health-related quality of life is very good. Based on the data obtained from the survey, scores ranging from 0 to 100 are calculated separately for 8 distinct sub-dimensions and for the 2 main components into which these dimensions are grouped.

8 weeks
Biodex Balance Scale
Tidsramme: 8 weeks

Patients' static balance will be measured using the Biodex Balance System®. Patients will be asked to maintain a balanced standing position on the static platform. The anteroposterior index, mediolateral index, and overall index will be evaluated with eyes open and eyes closed. Each position will be tested three times, and the average value will be recorded. For dynamic balance, level two of the 8-level resistance scale (1 = least stable, 8 = most stable) will be used.

8 weeks
Beck Depression Inventory
Tidsramme: 8 weeks

It is widely used to assess the severity of depression in patients. It is a questionnaire consisting of 21 items. The questionnaire has a total score ranging from 0 to 63 points. A high total score indicates a high level of depression severity.

8 weeks
Mini-Mental State Examination
Tidsramme: 8 weeks

The Mini-Mental test, which measures cognitive functions quickly and in a standardized manner, will be administered in the clinical setting; memory, attention, language, and visuospatial skills are assessed. The total score for the 11 items across these five domains ranges from 0 to 30. A high score in the assessment indicates normal mental functions, while a low score points to cognitive impairment or dementia.

8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. februar 2027

Datoer for studieregistrering

Først innsendt

13. oktober 2026

Først innsendt som oppfylte QC-kriteriene

13. oktober 2026

Først lagt ut (Faktiske)

20. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere