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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04099953
Other study ID # 23/23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date June 30, 2019

Study information

Verified date September 2019
Source Atilim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 30, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Turkey Atilim University Gölbasi Ankara

Sponsors (1)

Lead Sponsor Collaborator
NAIME ULUG

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of The Upper Extremity Functional Level 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 Evaluation of Physical Activity Level 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.
Secondary Evaluation of Physical Function Level 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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