Exercise TherapyActyren-HDNCT06883968
Therapeutic Exercise Programme to Improve the Functional Capacities, Depression and Anxiety of Patients With Chronic Kidney Disease During Haemodialysis Sessions.
A study testing Therapeutic exercise during hemodialysis session in people with Exercise Therapy and Chronical Kidney Disease, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial summary
Therapeutic Exercise During Outpatient Hemodialysis Treatment for Patients with Chronic Kidney Disease Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Exercise Therapy, Chronical Kidney Disease
- What is being tested?
- Therapeutic exercise during hemodialysis session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2024to 27 Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Treated for a minimum of 3 months with HD
- With clinical stability (good tolerance to sessions expressed as stable vital signs during the session)
- Voluntarily and with prior signed informed consent, have agreed to participate in the study
Who cannot join
- Physical or cognitive limitations that prevent following the intervention program
- Cardiovascular problems (unstable angina, uncontrolled arrhythmia, decompensated heart failure, pericarditis or myocarditis, severe untreated mitral or aortic stenosis)
- Uncontrolled arterial hypertension (SBP > 200 mmHg and DBP > 120 mmHg)
- Uncontrolled diabetes
- Severe neuropathies
- Acute systemic infection
- Severe renal osteodystrophy
- Stroke (cerebrovascular accident, transient ischemic attack)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Social Sciences and Community Health. Research Group on Methodology, Methods, Models and Outcomes of Health and Social Sciences . Faculty of Health Sciences and Welfare. University of Vic-Central of Catalonia, Vic 08500, Spain
Vic, Barcelona, 08500
About this study
Official title: Effectiveness of a Therapeutic Physical Exercise Program During Outpatient Hospital Hemodialysis Treatment for the Improvement of Physical Capacity of Patients With Chronic Kidney Disease: A Randomized Controlled Multiple Cohort Clinical Trial
Therapeutic Exercise During Outpatient Hemodialysis Treatment for Patients with Chronic Kidney Disease
- Conditions
- Exercise Therapy, Chronical Kidney Disease
- Being tested
- Therapeutic exercise during hemodialysis session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise during hemodialysis sessionBehavioural
Participants in the intervention group will receive a therapeutic exercise program during hemodialysis sessions at the hospital. The physiotherapist, after assessing the participant, will plan a program with the sets and number of repetitions for the prescribed exercises based on the participant's condition.
In this exercise program, the lower and upper extremities will be worked on with the aim of improving strength, balance, as well as contributing to the improvement of the participant's quality of life and mood.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise intervention | Experimental | This group recibe one intervention demonstrated by a physiotherapist about therapeutic exercise to apply during hemodialysis session Receives: Behavioral: Therapeutic exercise during hemodialysis session |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
Physical capacity will be assessed using the Short Physical Performance Battery (SPPB) . The SPPB includes tests for balance, walking, and chair rise and sit.
For the balance test, participants must stand in three positions: feet together, semi-tandem, and tandem. To earn 1 point and proceed to the semi-tandem position, they must remain with their feet together for at least 10 seconds. The same procedure applies for the tandem position.
The walking test involves walking 4 meters at a comfortable pace, with the option of using assistive devices if necessary. The test is repeated twice, and the fastest time is selected. The scoring system is: 4 points for less than 4.82 seconds; 3 points for 4.48-6.20 seconds; 2 points for 6.21-8.70 seconds; 1 point for more than 8.70 seconds; and 0 points if the test is not completed.
For the chair rise and sit test, participants must stand up and sit down 5 times as quickly as possible with arms crossed. The scoring is: 4 points for under 11.1
Measured: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
Secondary outcomes (4)
Euro Quality of Life - EQ-5D-5L
Quality of life will be assessed using the Euro Quality of Life - EQ-5D-5L questionnaire . This is a self-administered questionnaire consisting of two pages: the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale. The descriptive system includes 5 dimensions (mobility, self-care, daily activities, pain/discomfort, anxiety/depression), and each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. To complete the questionnaire, the patient is asked to indicate their health status by marking the box that corresponds to the most appropriate level for each of the 5 dimensions. This results in a single-digit number, and when combined across the 5 dimensions, it forms a 5-digit number that describes the patient's health status. The EQ Visual Analogue Scale records the patient's perceived health status on a 20 cm vertical analogue scale. This information can be used quantitatively.
Measured: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
Barthel Index
Functional independence during activities of daily living will be assessed using the Barthel Index. The Barthel Index is a 10-item scale. Each item assesses whether the patient is able to perform a task independently (2 points), with some assistance (1 point), or is unable to perform the task independently (0 points). The score for each item is summed, and the total is multiplied by 5 to convert it into a score ranging from 0 to 100. The higher the score, the greater the functional independence during activities of daily living .
Measured: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
HandGrip strength
Handgrip strength of the dominant hand will be measured using the Jamar Hand Dynamometer (Sammons Preston, Inc, Molingbrook, IL) . The dominant hand will be determined according to the lateral preference inventory . The measurement will be taken with the participants seated in an upright position, with the arm to be used unsupported and parallel to the body. The grip width of the dynamometer will be adjusted to fit the size of each participant's hand so that the middle phalanges are placed on the inside of the handle. Participants will be asked to exert maximum force, starting with a submaximal trial to familiarize them with the testing procedure. The hand dynamometer has an intraclass correlation coefficient of 0.99 .
Measured: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
Hospital Anxiety and Depression Scale (HADS)
Symptoms of anxiety and depression will be assessed using the Spanish version of the self-administered Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items that assess the possible presence of depression and anxiety states in patients attending a non-psychiatric outpatient healthcare center. The HADS includes the anxiety and depression subscales, each consisting of 7 items scored using a 4-point Likert scale (e.g., [0] as usual, [1] not quite, [2] just a little, [3] never), giving a total score of 21 points for each subscale. This tool is validated for the Spanish population and has shown excellent internal consistency for its total score (alpha coefficient = 0.90), and moderate internal consistency for the anxiety (0.85) and depression (0.84) subscales .
Measured: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start10 Jun 2024
- Primary completion28 Jun 2025
- Study completion27 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TherapyStudies 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
- Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Font, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883968
- Sponsor's protocol ID
- ACTYREN-01
- Acronym
- Actyren-HD
- Status last verified
- Jul 2026
- First submitted
- 18 Feb 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the event that we decide to share the study data with other researchers, this will be done while maintaining anonymity or with additional consent from the participants.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Therapeutic Physical Exercise Program During Outpatient Hospital Hemodialysis Treatment for the Improvement of Physical Capacity of Patients With Chronic Kidney Disease: A Randomized Controlled Multiple Cohort Clinical Trial
- ClinicalTrials.gov ID
- NCT06883968
- Acronym / sponsor ID
- Actyren-HD / ACTYREN-01
- Conditions
- Exercise Therapy, Chronical Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 28 Jun 2025 (actual)
- Study completion
- 27 Sep 2025 (actual)
- First posted
- 19 Mar 2025 (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.
Therapeutic Exercise During Outpatient Hemodialysis Treatment for Patients with Chronic Kidney Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise intervention | Experimental | Behavioral: Therapeutic exercise during hemodialysis sessionThis group recibe one intervention demonstrated by a physiotherapist about therapeutic exercise to apply during hemodialysis session |
| Control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Treated for a minimum of 3 months with HD
- With clinical stability (good tolerance to sessions expressed as stable vital signs during the session)
- Voluntarily and with prior signed informed consent, have agreed to participate in the study
Key exclusion criteria (8 listed)
- Physical or cognitive limitations that prevent following the intervention program
- Cardiovascular problems (unstable angina, uncontrolled arrhythmia, decompensated heart failure, pericarditis or myocarditis, severe untreated mitral or aortic stenosis)
- Uncontrolled arterial hypertension (SBP > 200 mmHg and DBP > 120 mmHg)
- Uncontrolled diabetes
- Severe neuropathies
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 exercise during hemodialysis sessionParticipants in the intervention group will receive a therapeutic exercise program during hemodialysis sessions at the hospital. The physiotherapist, after assessing the participant, will plan a program with the sets and number of repetitions for the prescribed exercises based on the participant's condition. In this exercise program, the lower and upper extremities will be worked on with the aim of improving strength, balance, as well as contributing to the improvement of the participant's quality of life and mood. | Behavioural | Therapeutic exercise intervention |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
Physical capacity will be assessed using the Short Physical Performance Battery (SPPB) . The SPPB includes tests for balance, walking, and chair rise and sit. For the balance test, participants must stand in three positions: feet together, semi-tandem, and tandem. To earn 1 point and proceed to the semi-tandem position, they must remain with their feet together for at least 10 seconds. The same procedure applies for the tandem position. The walking test involves walking 4 meters at a comfortable pace, with the option of using assistive devices if necessary. The test is repeated twice, and the fastest time is selected. The scoring system is: 4 points for less than 4.82 seconds; 3 points for 4.48-6.20 seconds; 2 points for 6.21-8.70 seconds; 1 point for more than 8.70 seconds; and 0 points if the test is not completed. For the chair rise and sit test, participants must stand up and sit down 5 times as quickly as possible with arms crossed. The scoring is: 4 points for under 11.1
4 secondary outcomes
Euro Quality of Life - EQ-5D-5L
Time frame: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
Barthel Index
Time frame: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
HandGrip strength
Time frame: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
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 24 Jul 2026.
- Individual participant dataSharing planned: No. In the event that we decide to share the study data with other researchers, this will be done while maintaining anonymity or with additional consent from the participants.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 during hemodialysis session in people with Exercise Therapy and Chronical Kidney Disease, run by University of Vic - Central University of Catalonia 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 4 inclusion and 8 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 24 Jul 2026. 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 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?
Short Physical Performance Battery (SPPB) (time frame: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)). 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 24 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.