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

Lead sponsor

University of Vic - Central University of Catalonia is the lead sponsor of 36 studies on the registry; 11 are open to participants now.

Study arms

• 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

• No intervention
  Control group

Interventions

• BehavioralTherapeutic 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.

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

   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)

Secondary outcomes

1. 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.

   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)

2. 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 .

   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)

3. 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 .

   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)

4. 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 .

   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)

Other outcomes

1. Age

   Age in years

   Time frame: Pre-intervention (A0)

2. Sex

   male or female

   Time frame: Pre-intervention (A0)

3. Location of the vascular access

   location of the vascular access in right or letf arm, or catheter

   Time frame: Pre-intervention (A0)

4. Duration of treatment with HD

   The time in years and months that the patient has been undergoing hemodialysis treatment

   Time frame: Pre-intervention (A0)

5. Charlson Comorbidity Index

   Screening for comorbidities

   Time frame: Pre-intervention (A0)

6. Weight

   weight in kilograms

   Time frame: Pre-intervention (A0)

7. Height

   height in meters

   Time frame: Pre-intervention (A0)

8. BMI

   weight and height will be combined to report BMI in kg/m\^2

   Time frame: Pre-intervention (A0)

9. Smoking

   Smoker: Yes or No

   Time frame: Pre-intervention (A0)

10. Alcholism

    Consumes alcohol regularly: Yes or No

    Time frame: Pre-intervention (A0)

Individual participant data

Plan to share: 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.