Chronic Kidney DiseasesDEXTRANCT06045442
Dialysis Exercise With a Bed Compatible Leg TRAiningstool
A study testing Intradialytic exercise training in people with Chronic Kidney Diseases and Hemodialysis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This study is a randomised controlled intervention trial for dialysis patients with chronic kidney disease (n=32). The aim of this study is to test the effectiveness of an intradialytic training with a simple bed compatible trainingstool in comparison to a control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Hemodialysis
- What is being tested?
- Intradialytic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2023to 8 Aug 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 ≥ 18 years
- Patients who started dialysis more than 3 months ago
- Patients must be mentally and physically able to participate in exercise
Who cannot join
- Patients who are not mentally or physically able to participate in intradialytic exercise. These include patients with uncontrolled high blood pressure and uncontrolled diabetes mellitus, diseases that impair physical performance or/and could be aggravated by activity, such as ischaemic cardiopathy or symptoms associated with coronary heart disease, chronic coronary heart disease, chronic lung disease and orthopaedic conditions that make exercise impossible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise During Hemodialysis With a Bed Compatible Trainingstool: a Randomized Controlled Trial
This study is a randomised controlled intervention trial for dialysis patients with chronic kidney disease (n=32). The aim of this study is to test the effectiveness of an intradialytic training with a simple bed compatible trainingstool in comparison to a control group.
Read the detailed description
Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning and after 2 months regarding their body composition, physical performance, fatigue and quality of life. The control group receives usual care. The intervention group receives an intradialytic exercise training with a bed compatible trainingstool.
- Conditions
- Chronic Kidney Diseases, Hemodialysis
- Being tested
- Intradialytic exercise training, Control
- Keywords
- Dialysis, Intradialytic exercise, Hemodialysis training
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic exercise trainingBehavioural
The patients in the intervention group will receive 3 months of endurance training, 2x/week for 30 min. 5 min of this should be a warm-up, 20 min of exertion and 5 min of cool down. The warm-up and cool-down should be equivalent to a very light load (Borg scale 9), whereas the exertion phase should be exhausting for the patients (Borg scale 14-15).
ControlBehavioural
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 3 months intradialytic exercise intervention: 30 minutes of endurance training at the dialysis unit with a dialysis training device, twice a week. Receives: Behavioral: Intradialytic exercise training |
| Control | Active comparator | Usual Care Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit-to-stand test (STS60)
measured in number of repetitions in 60 seconds
Measured: 3 month
Timed-up-and-go test (TUG)
measured in time (seconds)
Measured: 3 month
Secondary outcomes (5)
muscle mass
measured in kg by bio-impedance analysis
Measured: 3 month
body fat mass
measured in kg by bio-impedance analysis
Measured: 3 month
Quality of life by Kidney Disease Quality of Life Instrument (KDQOL)
measured in change of scale by questionnaire (higher Score = better health; Questions are combined to form items and the average is calculated; Range from 0-100)
Measured: 3 month
Fatigue by Fatigue Assessment Scale (FAS)
measured in change of scale by questionnaire (scores can range from 10 (lowest level of fatigue) to 50 (highest level of fatigue)
Measured: 3 month
activity by Freiburg Questionnaire of physical activity
measured in change of scale by questionnaire (The higher the score, the more active the participant. the lowest level would be a score of 0)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start3 May 2023
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment in 1:1 ratio to either the intervention group (intradialytic exercise; twice a week for 30 min per dialysis session) or control group (Usual care)
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Schiffer, Prof., Study director, Universitätsklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045442
- Sponsor's protocol ID
- 23-40-B
- Acronym
- DEXTRA
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 22 Sep 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise During Hemodialysis With a Bed Compatible Trainingstool: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06045442
- Acronym / sponsor ID
- DEXTRA / 23-40-B
- Conditions
- Chronic Kidney Diseases, Hemodialysis
- Keywords
- Dialysis, Intradialytic exercise, Hemodialysis training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 21 Sep 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.
This study is a randomised controlled intervention trial for dialysis patients with chronic kidney disease (n=32). The aim of this study is to test the effectiveness of an intradialytic training with a simple bed compatible trainingstool in comparison to a control group.
Detailed description
Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning and after 2 months regarding their body composition, physical performance, fatigue and quality of life. The control group receives usual care. The intervention group receives an intradialytic exercise training with a bed compatible trainingstool.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random assignment in 1:1 ratio to either the intervention group (intradialytic exercise; twice a week for 30 min per dialysis session) or control group (Usual care)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Intradialytic exercise training3 months intradialytic exercise intervention: 30 minutes of endurance training at the dialysis unit with a dialysis training device, twice a week. |
| Control | Active comparator | Behavioral: ControlUsual 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 ≥ 18 years
- Patients who started dialysis more than 3 months ago
- Patients must be mentally and physically able to participate in exercise
Key exclusion criteria (1 listed)
- Patients who are not mentally or physically able to participate in intradialytic exercise. These include patients with uncontrolled high blood pressure and uncontrolled diabetes mellitus, diseases that impair physical performance or/and could be aggravated by activity, such as ischaemic cardiopathy or symptoms associated with coronary heart disease, chronic coronary heart disease, chronic lung disease and orthopaedic conditions that make exercise impossible.
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 |
|---|---|---|
| Intradialytic exercise trainingThe patients in the intervention group will receive 3 months of endurance training, 2x/week for 30 min. 5 min of this should be a warm-up, 20 min of exertion and 5 min of cool down. The warm-up and cool-down should be equivalent to a very light load (Borg scale 9), whereas the exertion phase should be exhausting for the patients (Borg scale 14-15). | Behavioural | Intervention |
| ControlUsual care | Behavioural | Control |
Primary outcome
Sit-to-stand test (STS60)
Time frame: 3 month
measured in number of repetitions in 60 seconds
Timed-up-and-go test (TUG)
Time frame: 3 month
measured in time (seconds)
5 secondary outcomes
muscle mass
Time frame: 3 month
body fat mass
Time frame: 3 month
Quality of life by Kidney Disease Quality of Life Instrument (KDQOL)
Time frame: 3 month
Fatigue by Fatigue Assessment Scale (FAS)
Time frame: 3 month
activity by Freiburg Questionnaire of physical activity
Time frame: 3 month
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 22 Sep 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.
Mario Schiffer, Prof. study director
Universitätsklinikum Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic exercise training in people with Chronic Kidney Diseases and Hemodialysis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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: finished, as of the sponsor's last update on 22 Sep 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 Germany. 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?
Sit-to-stand test (STS60) (time frame: 3 month). The study lists 2 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 22 Sep 2023.