Renal TransplantNCT05876507
Effect of Progressive Exercise on Renal Transplant Patients
A study testing Progressive relaxation exercise in people with Renal Transplant and Fatigue, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this interventional study is to determine the effect of progressive relaxation exercises on the vital signs and fatigue levels of patients with renal transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant, Fatigue, Vital Signs
- What is being tested?
- Progressive relaxation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2023to 15 Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients underwent renal transplant within one year from the beginning of the study
- Patients having no communication problems
- Patients having a smart phone either own or o family member
Who cannot join
- Patients having musculoskeletal, cardiopulmonary, or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University Hospital
Ankara, Çankaya, 06490
Şeyda Uzun Yağız, RN, +905392791581, seydauzun97@gmail.com
Sevcan Avcı Işık, PhD, RN, +905433177016, sevcanavci@baskent.edu.tr
About this study
Official title: The Effects of Progressive Exercises on the Vital Signs and Fatigue in Patients With Renal Transplant
The goal of this interventional study is to determine the effect of progressive relaxation exercises on the vital signs and fatigue levels of patients with renal transplantation.
Read the detailed description
Renal transplant patients experience intense level of fatigue as well as vital sign problems due to treatment protocol. This research is designed to determine the effect of progressive relaxation exercises on vital signs and fatigue level of patients with renal transplantation.
In this study, the participants will be randomized in a single blind manner (participant) to either intervention (4 week exercise program) or control (routine care) groups.
- Conditions
- Renal Transplant, Fatigue, Vital Signs, Progressive Relaxation Exercise, Nursing
- Being tested
- Progressive relaxation exercise
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exerciseBehavioural
Progressive relaxation exercises will take 25-30 minutes of patients daily.
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | Participants will receive a training about progressive relaxation exercises on the first day, then given an audio-record containing instructions about exercises. They will perform exercises at home for 4 week and revisited by the principal investigator at the 2nd and 4th week. Receives: Behavioral: Progressive relaxation exercise |
| Control | No intervention | Participants will receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure
Maintaining or normalizing systolic and blood pressure within normal range (systolic: 90-140 mmHg; diastolic 60-90 mmHg)
Measured: Change fron baseline at 4th week
fatigue level
Fatigue Severity Scale is a valid and 7-point Likert type scale. Possible scores range from 9-63. Higher scores indicate high level of fatigue. A score of 36 points or over indicates severe fatigue (Change= Lower score from the scale at the end of intervention compared to baseline).
Measured: Change from baseline at 4th week
Heart rate
Maintaining or normalizing heart rate within normal range (60 to 100 bpm)
Measured: Change from baseline at 4th week
Respiratory rate
Maintaining or normalizing respiratory rate within normal range (12-20 breath per minute)
Measured: Change from baseline at 4th week
Body temperature
Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement)
Measured: Change from baseline at 4th week
Oxygen saturation
Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry)
Measured: Change from baseline at 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start13 Feb 2023
- Primary completion15 May 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single blind, randomized controlled study. The intervention group will receive an audio record explaining progressive relaxation exercise. Then participants will undergo training about the exercises. After training, the intervention group will perform the exercises at home by their own. The exercises will be performed everyday for 4 weeks about 25-30 minutes. Principal investigator will check the participants weekly about implementation of exercises.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda Uzun Yagız, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876507
- Sponsor's protocol ID
- KA22/239
- Status last verified
- May 2023
- First submitted
- 9 Mar 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make IPD available. The researchers will decide later.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Progressive Exercises on the Vital Signs and Fatigue in Patients With Renal Transplant
- ClinicalTrials.gov ID
- NCT05876507
- Acronym / sponsor ID
- KA22/239
- Conditions
- Renal Transplant, Fatigue, Vital Signs, Progressive Relaxation Exercise, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 25 May 2023 (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.
The goal of this interventional study is to determine the effect of progressive relaxation exercises on the vital signs and fatigue levels of patients with renal transplantation.
Detailed description
Renal transplant patients experience intense level of fatigue as well as vital sign problems due to treatment protocol. This research is designed to determine the effect of progressive relaxation exercises on vital signs and fatigue level of patients with renal transplantation.
In this study, the participants will be randomized in a single blind manner (participant) to either intervention (4 week exercise program) or control (routine care) groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single blind, randomized controlled study. The intervention group will receive an audio record explaining progressive relaxation exercise. Then participants will undergo training about the exercises. After training, the intervention group will perform the exercises at home by their own. The exercises will be performed everyday for 4 weeks about 25-30 minutes. Principal investigator will check the participants weekly about implementation of exercises.
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Behavioral: Progressive relaxation exerciseParticipants will receive a training about progressive relaxation exercises on the first day, then given an audio-record containing instructions about exercises. They will perform exercises at home for 4 week and revisited by the principal investigator at the 2nd and 4th week. |
| Control | No intervention | –Participants will receive routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients underwent renal transplant within one year from the beginning of the study
- Patients having no communication problems
- Patients having a smart phone either own or o family member
Key exclusion criteria (1 listed)
- Patients having musculoskeletal, cardiopulmonary, or psychiatric disorders
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 |
|---|---|---|
| Progressive relaxation exerciseProgressive relaxation exercises will take 25-30 minutes of patients daily. | Behavioural | exercise |
Primary outcome
Systolic and diastolic blood pressure
Time frame: Change fron baseline at 4th week
Maintaining or normalizing systolic and blood pressure within normal range (systolic: 90-140 mmHg; diastolic 60-90 mmHg)
fatigue level
Time frame: Change from baseline at 4th week
Fatigue Severity Scale is a valid and 7-point Likert type scale. Possible scores range from 9-63. Higher scores indicate high level of fatigue. A score of 36 points or over indicates severe fatigue (Change= Lower score from the scale at the end of intervention compared to baseline).
Heart rate
Time frame: Change from baseline at 4th week
Maintaining or normalizing heart rate within normal range (60 to 100 bpm)
Respiratory rate
Time frame: Change from baseline at 4th week
Maintaining or normalizing respiratory rate within normal range (12-20 breath per minute)
Body temperature
Time frame: Change from baseline at 4th week
Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement)
Oxygen saturation
Time frame: Change from baseline at 4th week
Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available. The researchers will decide later.
Related trials for Renal Transplant
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive relaxation exercise in people with Renal Transplant and Fatigue, run by Baskent University 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şeyda Uzun Yağız, RN (+905392791581, seydauzun97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic blood pressure (time frame: Change fron baseline at 4th week). The study lists 6 primary outcomes in all. 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 25 May 2023.