- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04099953
Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?
Atılım University, Physiotherapy and Rehabilitation Department
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Gölbaşı, Ankara, Turkey, 06830
- Atılım University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Experimental: Control group
Healthy individuals
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of The Upper Extremity Functional Level
Time Frame: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Physical Activity Level
Time Frame: 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) .
|
Evaluations were made after hemodialysis patients rested for half an hour after treatment.
|
|
Evaluation of Physical Function Level
Time Frame: 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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatma Cansu AKTAŞ, MsC, Atılım University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Kidney Diseases
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
Centre Hospitalier le MansLe Mans UniversiteWithdrawnFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage3 | Chronic Kidney Failure | Chronic Kidney Disease, Stage 4 (Severe)
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
Texas A&M UniversityWithdrawnChronic Kidney FailureUnited States
-
University of the State of Santa CatarinaUnknownKidney Diseases | Chronic Kidney Diseases | Hemodialysis | Chronic Renal Insufficiency | Renal Dialysis | Chronic Kidney Insufficiency | Chronic Renal DiseasesBrazil
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
-
Benha UniversityCompletedChronic Kidney Diseases | Chronic Kidney Disease 5DEgypt
Clinical Trials on Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels
-
Sultan Abdulhamid Han Training and Research Hospital...CompletedPain | Breast Cancer | Lymphedema | Myofascial Pain Syndrome | Breast Cancer Female | Lymphedema of Upper LimbTurkey (Türkiye)
-
Istanbul Gelisim UniversityActive, not recruiting
-
Atılım UniversityCompletedCOVID-19 | Sport Performance, Professional Overhead AthletesTurkey
-
Sultan Abdulhamid Han Training and Research Hospital...CompletedChronic Pain | Subacromial Impingement Syndrome | Shoulder Pain | Rotator Cuff LesionTurkey (Türkiye)
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Stichting StofwisselkrachtRecruitingLong-chain Fatty Acid Oxidation DisordersNetherlands
-
Istanbul Medeniyet UniversityNot yet recruiting
-
University GhentRecruitingAthletic InjuriesBelgium
-
Hacettepe UniversityCompleted
-
Gulf Medical UniversityRecruiting
-
Wroclaw University of Health and Sport SciencesUniversidad de ZaragozaActive, not recruitingNeck Pain | Cervical Spine | Manual TherapyPoland