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Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099953
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
NAİME ULUG, Atılım University

Brief Summary:
This study was planned to determine the effects of upper extremity functional capacity, physical activity level and physical functions of patients receiving hemodialysis treatment.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Diagnostic Test: Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels Not Applicable

Detailed Description:
Upper extremity functional capacity, physical activity level and physical functions were evaluated in healthy subjects and hemodialysis patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Study
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Atılım University, Physiotherapy and Rehabilitation Department
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dialysis patients
Dialysis patients were evaluated by objective diagnostic tests.
Diagnostic Test: Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels
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
Diagnostic Test: Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels
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.




Primary Outcome Measures :
  1. 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 .


Secondary Outcome Measures :
  1. 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) .

  2. 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 .




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099953


Locations
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Turkey
Atılım University
Gölbaşı, Ankara, Turkey, 06830
Sponsors and Collaborators
NAİME ULUG
Investigators
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Principal Investigator: Fatma Cansu AKTAŞ, MsC Atılım University
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Responsible Party: NAİME ULUG, Physiotherapist, PhD, Associate Professor, Atılım University
ClinicalTrials.gov Identifier: NCT04099953    
Other Study ID Numbers: 23/23
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NAİME ULUG, Atılım University:
Hemodialysis
chronic renal failure
upper extremity
physical activity
physical function
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency