Chronic Kidney DiseasesNCT04099953
Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?
A study testing Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels in people with Chronic Kidney Diseases, run by NAİME ULUG at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals with orthopedic problems associated with chronic renal failure,
- Upper limb functions affected
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atılım University, Physiotherapy and Rehabilitation Department
This study was planned to determine the effects of upper extremity functional capacity, physical activity level and physical functions of patients receiving hemodialysis treatment.
Read the detailed description
Upper extremity functional capacity, physical activity level and physical functions were evaluated in healthy subjects and hemodialysis patients.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels
- Keywords
- Hemodialysis, chronic renal failure, upper extremity, physical activity, physical function
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand grip, joint range of motion , functional level of the upper extremity, physical activity levelsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| dialysis patients | Experimental | Dialysis patients were evaluated by objective diagnostic tests. Receives: Diagnostic Test: Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels |
| Control group | Experimental | Healthy individuals Receives: Diagnostic Test: Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
Secondary outcomes (2)
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) .
Measured: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
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 .
Measured: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Apr 2018
- Primary completion1 Jan 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NAİME ULUG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NAİME ULUG, Atılım University
- Investigators
- Fatma Cansu AKTAŞ, MsC, Principal investigator, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099953
- Sponsor's protocol ID
- 23/23
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atılım University, Physiotherapy and Rehabilitation Department
- ClinicalTrials.gov ID
- NCT04099953
- Acronym / sponsor ID
- 23/23
- Conditions
- Chronic Kidney Diseases
- Keywords
- Hemodialysis, chronic renal failure, upper extremity, physical activity, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NAİME ULUGUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| dialysis patients | Experimental | Diagnostic Test: Hand grip, joint range of motion , functional level of the upper extremity, physical activity levelsDialysis patients were evaluated by objective diagnostic tests. |
| Control group | Experimental | Diagnostic Test: Hand grip, joint range of motion , functional level of the upper extremity, physical activity levelsHealthy individuals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In study group,
- with cooperation
- hemodialysis treatment for at least 3 months
- with single-sided fistula
- In the control group,
Key exclusion criteria (2 listed)
- Individuals with orthopedic problems associated with chronic renal failure,
- Upper limb functions affected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand grip, joint range of motion , functional level of the upper extremity, physical activity levelsHand 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. | Diagnostic test | Control group, dialysis patients |
Primary outcome
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 .
2 secondary outcomes
Evaluation of Physical Activity Level
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Cansu AKTAŞ, MsC principal investigator
Atılım University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels in people with Chronic Kidney Diseases, run by NAİME ULUG at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of The Upper Extremity Functional Level (time frame: Evaluations were made after hemodialysis patients rested for half an hour after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.