Kidney DiseasesNCT03416140
Effectiveness Chronic Kidney Disease & Therapeutic Exercise
A study testing Therapeutic Exercise in people with Kidney Diseases and Exercise, run by Universidad de León at 1 site in Spain.
Trial summary
The purpose of this study is to assess the effectiveness and safety of the therapeutic exercise effects in patients with chronic kidney disease. An randomized clinical trial is carried out. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Exercise
- What is being tested?
- Therapeutic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2018to 15 Jun 2021
- 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 with chronic kidney disease
Who cannot join
- Cognitive impairment and non signed consent inform form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of the Therapeutic Exercise in Patients With Chronic Kidney Disease
The purpose of this study is to assess the effectiveness and safety of the therapeutic exercise effects in patients with chronic kidney disease. An randomized clinical trial is carried out. A total sample of 70 patients with chronic kidney disease is recruited and divided into a therapeutic exercise group and a control group. The kidney function (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment start.
- Conditions
- Kidney Diseases, Exercise
- Being tested
- Therapeutic Exercise
- Medical subject headings
- Kidney Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ExerciseOther
30 minutes per day of therapeutic exercise
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise | Experimental | Not described Receives: Other: Therapeutic Exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney function
Creatinine clearance
Measured: Change from Baseline creatinine clearance at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start15 Feb 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad de León
- Investigators
- Pierre Neyra Bohórquez, MD, Principal investigator, Nephrology Unit, Galdakao Hospital, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416140
- Sponsor's protocol ID
- ERC_ULE_II
- Status last verified
- Mar 2020
- First submitted
- 23 Jan 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the Therapeutic Exercise in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03416140
- Acronym / sponsor ID
- ERC_ULE_II
- Conditions
- Kidney Diseases, Exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 30 Jan 2018 (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 purpose of this study is to assess the effectiveness and safety of the therapeutic exercise effects in patients with chronic kidney disease. An randomized clinical trial is carried out. A total sample of 70 patients with chronic kidney disease is recruited and divided into a therapeutic exercise group and a control group. The kidney function (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment start.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise | Experimental | Other: Therapeutic Exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic kidney disease
Key exclusion criteria (1 listed)
- Cognitive impairment and non signed consent inform form
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 |
|---|---|---|
| Therapeutic Exercise30 minutes per day of therapeutic exercise | Other | Therapeutic exercise |
Primary outcome
Kidney function
Time frame: Change from Baseline creatinine clearance at 1 month
Creatinine clearance
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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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.
Pierre Neyra Bohórquez, MD principal investigator
Nephrology Unit, Galdakao Hospital, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercise in people with Kidney Diseases and Exercise, run by Universidad de León at 1 site in Spain.
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 1 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: withdrawn, as of the sponsor's last update on 25 Mar 2020. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Kidney function (time frame: Change from Baseline creatinine clearance at 1 month). 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 Mar 2020.