- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04099953
Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?
Atılım University, Physiotherapy and Rehabilitation Department
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Ankara
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Gölbaşı, Ankara, Truthahn, 06830
- Atılım University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion criteria:
In study group,
- with cooperation
- hemodialysis treatment for at least 3 months
- with single-sided fistula
In the control group,
- healthy volunteers with no history of trauma or surgery in the upper extremity,
- with cooperating
Exclusion Criteria:
- Individuals with orthopedic problems associated with chronic renal failure,
- Upper limb functions affected
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: dialysis patients
Dialysis patients were evaluated by objective diagnostic tests.
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Hand grip force with Jamar Hand Dynamometer, joint range of motion with Baseline Digital Goniometer, functional level of the upper extremity with the Shoulder-Arm and Hand Problems Questionnaire(DASH), physical activity levels with International Physical Activity Questionnaire Short Form(IPAQ-short form) and physical functions with Human Activity Profile (HAP) were evaluated.
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Experimental: Control group
Healthy individuals
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Hand grip force with Jamar Hand Dynamometer, joint range of motion with Baseline Digital Goniometer, functional level of the upper extremity with the Shoulder-Arm and Hand Problems Questionnaire(DASH), physical activity levels with International Physical Activity Questionnaire Short Form(IPAQ-short form) and physical functions with Human Activity Profile (HAP) were evaluated.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Evaluation of The Upper Extremity Functional Level
Zeitfenster: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
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Turkish version of the Shoulder, Arm and Hand Problems Questionnaire (The DASH-T) was used to asses the functional level of the upper extremity.
Turkish version of the shoulder, arm and hand problems questionnaire consists of 30 questions.
The first 20 questions are to examine physical competence, and the last 10 questions question pain and related functional and environmental constraints.
As the score is closer to zero, the functional level of the person is high; as the score is far from zero the functional level of the person is low .
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Evaluations were made after hemodialysis patients rested for half an hour after treatment.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Evaluation of Physical Activity Level
Zeitfenster: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
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To asses the level of physical activity, The Turkish version of International Physical Activity Questionnaire Short Form was used .
In the turkish version of international physical activity questionnaire short form, physical activities were made at least 10 minutes at a time.
In the last 7 days of the survey; Severe physical activity duration (min), moderate physical activity duration (min), walking and one day sitting time (min) were questioned.
According to the total physical activity score, the physical activity levels of the participants were classified as low level (under 600 MET min /week), intermediate level (600-3000 MET-min /week) and high level (over 3000 MET-min / week) .
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Evaluations were made after hemodialysis patients rested for half an hour after treatment.
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Evaluation of Physical Function Level
Zeitfenster: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
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The Human Activity Profile (HAP) was used to measure the physical function level. Human activity profile is a scale consisting of 94 items developed to determine the level of physical function in healthy individuals or individuals with chronic diseases at different ages . For each of the 94 items the respondent is asked to indicate whether they are still doing the activity, stopped doing the activity or have never done the activity before. Two scores are calculated: the maximum activity score (MAS) and the adjusted activity score (AAS). The physical activity level of the person is in one of 3 subgroups according to the adjusted activity score: <53 points: insufficient activity level, 53-74 points: moderately active and > 74 points: active . |
Evaluations were made after hemodialysis patients rested for half an hour after treatment.
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Fatma Cansu AKTAŞ, MsC, Atılım University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 23/23
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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