Back to resultsDoes Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels
Sponsored by
About this trial
This is an interventional screening trial for Chronic Kidney Diseases focused on measuring Hemodialysis, chronic renal failure, upper extremity, physical activity, physical function
Eligibility 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
Sites / Locations
- Atılım University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
dialysis patients
Control group
Arm Description
Dialysis patients were evaluated by objective diagnostic tests.
Healthy individuals
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
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) .
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 .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04099953
Brief Title
Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?
Official Title
Atılım University, Physiotherapy and Rehabilitation Department
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
NAİME ULUG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Upper extremity functional capacity, physical activity level and physical functions were evaluated in healthy subjects and hemodialysis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Hemodialysis, chronic renal failure, upper extremity, physical activity, physical function
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dialysis patients
Arm Type
Experimental
Arm Description
Dialysis patients were evaluated by objective diagnostic tests.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Healthy individuals
Intervention Type
Diagnostic Test
Intervention Name(s)
Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels
Intervention Description
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 Measure Information:
Title
Evaluation of The Upper Extremity Functional Level
Description
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 .
Time Frame
Evaluations were made after hemodialysis patients rested for half an hour after treatment.
Secondary Outcome Measure Information:
Title
Evaluation of Physical Activity Level
Description
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) .
Time Frame
Evaluations were made after hemodialysis patients rested for half an hour after treatment.
Title
Evaluation of Physical Function Level
Description
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 .
Time Frame
Evaluations were made after hemodialysis patients rested for half an hour after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Cansu AKTAŞ, MsC
Organizational Affiliation
Atılım University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atılım University
City
Gölbaşı
State/Province
Ankara
ZIP/Postal Code
06830
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?
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