Clinical trial NCT06883968: Therapeutic Exercise Programme to Improve the Functional Capacities, Depression and Anxiety of Patients with Chronic Kidney Disease During Haemodialysis Sessions.
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Exercise Therapy
Chronical Kidney Disease
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Therapeutic Exercise During Outpatient Hemodialysis Treatment for Patients with Chronic Kidney Disease


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: 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:
measure: Euro Quality of Life - EQ-5D-5L
timeFrame: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
measure: Barthel Index
timeFrame: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
measure: HandGrip strength
timeFrame: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
Other outcomes:
measure: Age
timeFrame: Pre-intervention (A0)
measure: Sex
timeFrame: Pre-intervention (A0)
measure: Location of the vascular access
timeFrame: Pre-intervention (A0)
measure: Duration of treatment with HD
timeFrame: Pre-intervention (A0)
measure: Charlson Comorbidity Index
timeFrame: Pre-intervention (A0)
measure: Weight
timeFrame: Pre-intervention (A0)
measure: Height
timeFrame: Pre-intervention (A0)
measure: BMI
timeFrame: Pre-intervention (A0)
measure: Smoking
timeFrame: Pre-intervention (A0)
measure: Alcholism
timeFrame: Pre-intervention (A0)
Locations:
city: Vic
country: Spain
facility: 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
state: Barcelona
Study officials:
References: