- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04099953
Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?
Atılım University, Physiotherapy and Rehabilitation Department
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ankara
-
Gölbaşı, Ankara, Kalkun, 06830
- Atılım University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: dialysis patients
Dialysis patients were evaluated by objective diagnostic tests.
|
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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of The Upper Extremity Functional Level
Tidsramme: 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 .
|
Evaluations were made after hemodialysis patients rested for half an hour after treatment.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluation of Physical Activity Level
Tidsramme: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
|
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.
|
|
Evaluation of Physical Function Level
Tidsramme: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
|
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.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Fatma Cansu AKTAŞ, MsC, Atılım University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23/23
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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