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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Exercise Therapy; Chronical Kidney Disease
• Intervention / Treatment: Behavioral: Therapeutic exercise during hemodialysis session

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Vic, Barcelona, Spain, 08500
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Therapeutic exercise intervention; This group recibe one intervention demonstrated by a physiotherapist about therapeutic exercise to apply during hemodialysis session	Behavioral: Therapeutic exercise during hemodialysis session; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 .	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 .	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 .	Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age in years	Pre-intervention (A0)
Sex	male or female	Pre-intervention (A0)
Location of the vascular access	location of the vascular access in right or letf arm, or catheter	Pre-intervention (A0)
Duration of treatment with HD	The time in years and months that the patient has been undergoing hemodialysis treatment	Pre-intervention (A0)
Charlson Comorbidity Index	Screening for comorbidities	Pre-intervention (A0)
Weight	weight in kilograms	Pre-intervention (A0)
Height	height in meters	Pre-intervention (A0)
BMI	weight and height will be combined to report BMI in kg/m^2	Pre-intervention (A0)
Smoking	Smoker: Yes or No	Pre-intervention (A0)
Alcholism	Consumes alcohol regularly: Yes or No	Pre-intervention (A0)

Collaborators and Investigators

• Sponsor: University of Vic - Central University of Catalonia

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Actual): June 28, 2024
• Study Completion (Estimated): June 27, 2025

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: ACTYREN-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No