Therapeutic Exercise Programme to Improve the Functional Capacities, Depression and Anxiety of Patients with Chronic Kidney Disease During Haemodialysis Sessions.

NCT06883968 | Active Not Recruiting

• 1 other identifier: ACTYREN-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Exercise Therapy; Chronical Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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)

  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 (10)

• Age

  Pre-intervention (A0)

• Sex

  Pre-intervention (A0)

• Location of the vascular access

  Pre-intervention (A0)

Study Arms (2)

Therapeutic exercise intervention

EXPERIMENTAL

This group recibe one intervention demonstrated by a physiotherapist about therapeutic exercise to apply during hemodialysis session

Behavioral: Therapeutic exercise during hemodialysis session

Control group

NO INTERVENTION

Interventions

Therapeutic exercise during hemodialysis session BEHAVIORAL

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.

Therapeutic exercise intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead

Study Sites (1)

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, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Comprehensive care and health services

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 19, 2025
• Study Start: June 10, 2024
• Primary Completion: June 28, 2024
• Study Completion: June 27, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)