NCT04099953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

September 19, 2019

Last Update Submit

September 20, 2019

Conditions

Keywords

Hemodialysischronic renal failureupper extremityphysical activityphysical function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Evaluation of Physical Activity Level

    Evaluations were made after hemodialysis patients rested for half an hour after treatment.

  • Evaluation of Physical Function Level

    Evaluations were made after hemodialysis patients rested for half an hour after treatment.

Study Arms (2)

dialysis patients

EXPERIMENTAL

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

Control group

EXPERIMENTAL

Healthy individuals

Diagnostic Test: Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels

Interventions

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.

Control groupdialysis patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals with orthopedic problems associated with chronic renal failure,
  • Upper limb functions affected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atılım University

Gölbaşı, Ankara, 06830, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicMotor Activity

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fatma Cansu AKTAŞ, MsC

    Atılım University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist, PhD, Associate Professor

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 23, 2019

Study Start

April 1, 2018

Primary Completion

January 1, 2019

Study Completion

June 30, 2019

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations