Physical ActivityNCT05166486
The Effect of Calisthenic Exercise on Aerobic Capacity, Muscle Strength and Quality of Life in Hemodialysis Patients
A study testing Calisthenic exercise in people with Physical Activity and Patient, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aimed this study is to examine the effects of calisthenic exercises on aerobic capacities, muscle strength and quality of life in patients receiving hemodialysis treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Physical Activity, Patient, Quality of Life
- What is being tested?
- Calisthenic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 Apr 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being treated in the Hemodialysis unit of Aydın Adnan Menderes University Faculty of Medicine Research and Application Hospital,
- Having good cognitive functions
- Not having regular exercise habits
- Not having a physical disability
- Being between 18-60 years old
- Speaking and understanding Turkish
- Being willing to participate in the study
Who cannot join
- Neurologically affected patients (such as cerebrovascular accident, Gullian Barre)
- Patients with musculoskeletal problems that prevent exercise
- Patients with advanced heart failure, patients with unstable angina pectoris
- Patients with chronic liver failure
- Patients with a history of cardiovascular events (recent within 12 months)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University Hospital
Aydin
About this study
Official title: The Effect of Calisthenic Exercise on Aerobic Capacity, Muscle Strength and Quality of Life in Hemodialysis Patients: a Single-blind Placebo-controlled Randomized Trial
The aimed this study is to examine the effects of calisthenic exercises on aerobic capacities, muscle strength and quality of life in patients receiving hemodialysis treatment.
Read the detailed description
The study is a randomized single-blind placebo-controlled study. . At the beginning and end of the study, all patients will be asked to answer questions including demographic information and a quality of life questionnaire for kidney patients. A 6-minute walking test and a 30-second sit-stand test will be applied by the research physiotherapist to measure their aerobic capacity. Again, a dynamometer will be used to measure muscle strength.
The hypotheses the investigators will test for this purpors; H0 Calisthenic exercise in hemodialysis patients increases aerobic capacity. H1Calisthenic exercise in hemodialysis patients increases muscle strength.H2 Calisthenic exercise in hemodialysis patients improves the quality of life.
- Conditions
- Physical Activity, Patient, Quality of Life, Hemodialysis
- Being tested
- Calisthenic exercise
- Keywords
- Exercise, Hemodialysis, Quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calisthenic exerciseOther
Exercises involving major muscle groups will be given. Before starting the calisthenic exercises, they will be asked to perform 10 repetitive warm-ups and breathing exercises. The intensity of the calisthenic exercises will be adjusted on a weekly basis.
Calisthenic exercises are repeated 10-15 times in the first and second weeks; third and fourth weeks 15-20 repetitive; In the five, six, seven and eight weeks, it will be done with 25-30 repetitions.
Patients will be asked to keep an exercise diary and weekly follow-ups will be made over the phone.
Within eight weeks, each patient will come for control twice a month and will be asked to perform the exercises individually under the supervision of a physiotherapist. Patients will be asked to do the exercises three times a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Calisthenic exercise | Experimental | The patients in the calisthenic exercise group will be given one-to-one hands-on calisthenic exercises by the research physiotherapist. They will be asked to do these exercises 3 times a week for 8 weeks. Patients will be followed up by asking whether they do their exercises or not. They will be asked to do the exercises twice a month for 8 weeks under the control of a physiotherapist. In this way, it will be ensured that the exercises are done correctly and that the patients do it completely. Receives: Other: Calisthenic exercise |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information Form
In the form prepared by the researchers with the support of the literature, there are questions about the socio-demographic characteristics of the participants such as gender, age, height, weight, educational status, how long they have been on dialysis, etc.
Measured: immediately after application
6 Min. Walking Test
It is a test method used for the Evaluation of Cardiovascular Endurance. The 6 Minute Walk Test (6MWT) is among the field tests among the cardiopulmonary exercise tests. The test has been proven to be safe, inexpensive and easy to apply. The six-minute walk test is a test that aims to evaluate the submaximal functional capacity by measuring the distance that patients can walk quickly on a hard flat surface in a 6-minute period, in a corridor varying between 30 m and 50 m in length. The 6 MWT is a submaximal exercise test, but correlates well with the maximal cardiovascular exercise test and is better tolerated than other walking tests and better reflects activities of daily living.
Measured: immediately after application
30 sec Sit and Stand Test
30-second sit-stand test to evaluate the dynamic balance and physical fitness lower extremity neuromuscular function levels of individuals It is applied. The test is started while the individual sits in an armless chair, approximately 43 cm high from the ground, in an upright position, with the feet in contact with the ground, with the arms crossed in front of the chest. After the start command is given to the individual, they are asked to come to the standing upright position and again to the sitting position from the determined position for 30 seconds. The number of complete take-offs completed by the individual for 30 seconds is determined.
Measured: immediately after application
Grip Force Measurement with Hand Held Dynamometer
The Jamar Dynamometer is the best known of such devices. During measurements, the hand is in the claw grip position, except for flexion at the metacarpophalangeal joints. The handle part can be adjusted to 5 different levels according to the size of the hand. The Jamar Dynamometer is the most widely used and most reliable grip strength measuring instrument.
Measured: immediately after application
Kidney Disease Quality of Life Questionnaire
This scale is a scale that is used to monitor patients with end-stage rtreatment effects and well-being by self-declaring. assesses quality of life on 8 generics (physical function, role limitations due to social problems, bodily pain, general health, social function, role limitations due to physical problems, energy and fatigue, mental health) and 12 disease-specifi c subscales (effects of kidney disease, symptom list, work status, burden of kidney disease, cognitive function, sexual function, quality of life social interaction, sleep, social support, dialysis staff encouragement, overall health, patient satisfaction). Each subscale is scored out of 100, with higher score indicating greater perceived health al diseasene and evaluates various
Measured: immediately after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start15 Nov 2021
- Primary completion15 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazan Ozturk, Aydin Adnan Menderes University
- Investigators
- Nazan Ozturk, PhD., Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166486
- Sponsor's protocol ID
- Elifibo22
- Status last verified
- May 2023
- First submitted
- 25 Nov 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Calisthenic Exercise on Aerobic Capacity, Muscle Strength and Quality of Life in Hemodialysis Patients: a Single-blind Placebo-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT05166486
- Acronym / sponsor ID
- Elifibo22
- Conditions
- Physical Activity, Patient, Quality of Life, Hemodialysis
- Keywords
- Exercise, Hemodialysis, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 22 Dec 2021 (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 aimed this study is to examine the effects of calisthenic exercises on aerobic capacities, muscle strength and quality of life in patients receiving hemodialysis treatment.
Detailed description
The study is a randomized single-blind placebo-controlled study. . At the beginning and end of the study, all patients will be asked to answer questions including demographic information and a quality of life questionnaire for kidney patients. A 6-minute walking test and a 30-second sit-stand test will be applied by the research physiotherapist to measure their aerobic capacity. Again, a dynamometer will be used to measure muscle strength.
The hypotheses the investigators will test for this purpors; H0 Calisthenic exercise in hemodialysis patients increases aerobic capacity. H1Calisthenic exercise in hemodialysis patients increases muscle strength.H2 Calisthenic exercise in hemodialysis patients improves the quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calisthenic exercise | Experimental | Other: Calisthenic exerciseThe patients in the calisthenic exercise group will be given one-to-one hands-on calisthenic exercises by the research physiotherapist. They will be asked to do these exercises 3 times a week for 8 weeks. Patients will be followed up by asking whether they do their exercises or not. They will be asked to do the exercises twice a month for 8 weeks under the control of a physiotherapist. In this way, it will be ensured that the exercises are done correctly and that the patients do it completely. |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being treated in the Hemodialysis unit of Aydın Adnan Menderes University Faculty of Medicine Research and Application Hospital,
- Having good cognitive functions
- Not having regular exercise habits
- Not having a physical disability
- Being between 18-60 years old
Key exclusion criteria (5 listed)
- Neurologically affected patients (such as cerebrovascular accident, Gullian Barre)
- Patients with musculoskeletal problems that prevent exercise
- Patients with advanced heart failure, patients with unstable angina pectoris
- Patients with chronic liver failure
- Patients with a history of cardiovascular events (recent within 12 months)
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 |
|---|---|---|
| Calisthenic exerciseExercises involving major muscle groups will be given. Before starting the calisthenic exercises, they will be asked to perform 10 repetitive warm-ups and breathing exercises. The intensity of the calisthenic exercises will be adjusted on a weekly basis. Calisthenic exercises are repeated 10-15 times in the first and second weeks; third and fourth weeks 15-20 repetitive; In the five, six, seven and eight weeks, it will be done with 25-30 repetitions. Patients will be asked to keep an exercise diary and weekly follow-ups will be made over the phone. Within eight weeks, each patient will come for control twice a month and will be asked to perform the exercises individually under the supervision of a physiotherapist. Patients will be asked to do the exercises three times a week for 8 weeks. | Other | Calisthenic exercise |
Primary outcome
Demographic Information Form
Time frame: immediately after application
In the form prepared by the researchers with the support of the literature, there are questions about the socio-demographic characteristics of the participants such as gender, age, height, weight, educational status, how long they have been on dialysis, etc.
6 Min. Walking Test
Time frame: immediately after application
It is a test method used for the Evaluation of Cardiovascular Endurance. The 6 Minute Walk Test (6MWT) is among the field tests among the cardiopulmonary exercise tests. The test has been proven to be safe, inexpensive and easy to apply. The six-minute walk test is a test that aims to evaluate the submaximal functional capacity by measuring the distance that patients can walk quickly on a hard flat surface in a 6-minute period, in a corridor varying between 30 m and 50 m in length. The 6 MWT is a submaximal exercise test, but correlates well with the maximal cardiovascular exercise test and is better tolerated than other walking tests and better reflects activities of daily living.
30 sec Sit and Stand Test
Time frame: immediately after application
30-second sit-stand test to evaluate the dynamic balance and physical fitness lower extremity neuromuscular function levels of individuals It is applied. The test is started while the individual sits in an armless chair, approximately 43 cm high from the ground, in an upright position, with the feet in contact with the ground, with the arms crossed in front of the chest. After the start command is given to the individual, they are asked to come to the standing upright position and again to the sitting position from the determined position for 30 seconds. The number of complete take-offs completed by the individual for 30 seconds is determined.
Grip Force Measurement with Hand Held Dynamometer
Time frame: immediately after application
The Jamar Dynamometer is the best known of such devices. During measurements, the hand is in the claw grip position, except for flexion at the metacarpophalangeal joints. The handle part can be adjusted to 5 different levels according to the size of the hand. The Jamar Dynamometer is the most widely used and most reliable grip strength measuring instrument.
Kidney Disease Quality of Life Questionnaire
Time frame: immediately after application
This scale is a scale that is used to monitor patients with end-stage rtreatment effects and well-being by self-declaring. assesses quality of life on 8 generics (physical function, role limitations due to social problems, bodily pain, general health, social function, role limitations due to physical problems, energy and fatigue, mental health) and 12 disease-specifi c subscales (effects of kidney disease, symptom list, work status, burden of kidney disease, cognitive function, sexual function, quality of life social interaction, sleep, social support, dialysis staff encouragement, overall health, patient satisfaction). Each subscale is scored out of 100, with higher score indicating greater perceived health al diseasene and evaluates various
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 10 May 2023.
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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.
Nazan Ozturk, PhD. principal investigator
Aydin Adnan Menderes 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 Calisthenic exercise in people with Physical Activity and Patient, run by Aydin Adnan Menderes 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 7 inclusion and 5 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 10 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?
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?
Demographic Information Form (time frame: immediately after application). The study lists 5 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 10 May 2023.