Health TrialsbyHealthPanel

Analysis of Effects of High-intensity Physical Exercise in Subjects With Dialyzed Chronic Kidney Disease and in Conservative Treatment

ConditionChronic Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCasa di Cura Dott. Pederzoli

About this trial

This study aims to analyze the effects of physical activity in patients with chronic kidney disease undergoing dialysis or conservative treatment. Patients will be randomized into two groups: combined exercise (high-intensity aerobic resistance + strength training) and control group

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signature of the informed consent

Patients with CKD stage 1 to 5 under conservative treatment

Patients undergoing chronic hemodialysis for at least 3 months

Age ≥ 18

Disqualifiers

Severe cardiovascular disease (NYHA class IV or hypertension class III)

TIA or myocardial ischemia within the last three months

Anatomical limitations

Health conditions detected during the stress test (CPET)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    All participants will be involved in the exercise training three times per week for 24 weeks: endurance exercise training, resistant exercise training

  • control

    Other intervention

    outcome measures

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: combined exerciseExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Gait speed (6MWT)

• Assess the effect of exercise on physical performance and quality of life on pa-tients with chronic kidney disease from stage 1 to end stage renal disease on maintenance haemodialysis or on conservative treatment

Time frame
through study completion, an average of 1 year
2

Physical performance (SPPB)

Time frame
through study completion, an average of 1 year
3

Cardiopulmonary capacity (CPET)

Time frame
through study completion, an average of 1 year
4

Lower limbs strength (1-RM)

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Nutritional status (24HR, FFQ)

Time frame
through study completion, an average of 1 year
2

Body composition (DEXA, BIVA)

Time frame
through study completion, an average of 1 year
3

Psychological and psychosocial conditions (BDI, MMSE)

Time frame
through study completion, an average of 1 year
4

Hemodynamic and vascular functions (SV, CO, HR, FBF, FMD, sPLM)

Time frame
through study completion, an average of 1 year

Other outcomes

1

effect of physical activity on mitochondrial activity

Investigate the effect of physical activity on mitochondrial activity by analyzing the expression of mitochondrial biomarkers, MOTS-c (mg)

Time frame
through study completion, an average of 1 year
2

Effect of physical activity on mitochondrial activity

Investigate the effect of physical activity on mitochondrial activity by analyzing the expression of mitochondrial biomarkers, humanin (mg)

Time frame
through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Casa di Cura Dott. Pederzoli

Lead sponsor

Source ClinicalTrials.gov
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