Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.

Frailty Clinical Trial

Official title:

Evaluating the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374537
• Other study ID #: 2017-0784
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2019
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: University of Illinois at Chicago
• Contact: Ilaria Santi
• Phone: 312-996-9594
• Email: isanti[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research is being done to better understand the impact of the use of a specific physical activity training program (GH Method) in dialysis/kidney disease patients.

Description:

The 12-Month Randomized Trial Group will include a total of 150 patients from UI Health (≥ 18 years of age), who are on dialysis, or have chronic kidney disease stage 4 (CKD 4 = GFR between 15 and 29) or have chronic kidney disease stage 5 (CKD 5 = GFR below 15) and are considered clinically debilitated by their direct healthcare professional will be enrolled. Randomization will be a 2:1 ratio (100 intervention, 50 control). The intervention arm will perform a 12-month exercise intervention which involves two days a week of personalized exercise rehabilitation. The control arm will receive no exercise intervention. Both arms of patients will be tested on various measures of health and function both at baseline (prior to intervention) at 6 months, and at 12 months (post intervention). This study will also investigate the effects of an exercise intervention on a subgroup of pre- and post- kidney transplant patients (PPKT Subgroup). This subgroup will include a total of 100 patients (≥ 18 years of age), who are on dialysis, or have CKD stage 4 or 5, and are considered clinically debilitated by their direct healthcare professional will be enrolled, or post- renal (kidney) transplant. This subgroup will perform 36 visits of exercise intervention which involves two days a week of personalized exercise rehabilitation. The Investigator will also utilize validated surveys and assessment tools to assess health issue management and depression severity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2027
• Est. primary completion date: May 22, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinically debilitated patients, currently on dialysis, or have CKD 4 (GFR between 15 and 29), or have CKD 5 (GFR below 15), or post- kidney transplant (for PPKT Subgroup only) as stated by patient's health care professional.
• Adequate cognitive ability to complete the questionnaires, give consent for the study and follow the physical and diet instructions

Exclusion Criteria:

• cardiac/pulmonary disease that contraindicate the physical training
• Unable to give consent
• Unable to travel to the training center

Related Conditions & MeSH terms

• Chronic Pain
• Dialysis; Complications
• Frailty
• Kidney Diseases
• Pain, Chronic

Intervention

Other:
• Muscle Therapy
Participants will attend 2 muscle therapy sessions a week for 12 months, for one hour each.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate at which subjects will see changes in their physical abilities.	Participants will see improvements in their physical abilities after 12 months in the exercise training sessions. This will be assessed by comparing baseline, 6 months, 12 months, using a Short Physical Performance Battery test. This test requires the assessment of walking speed (time to walk 3 meters), a balance test (standing in 3 different positions for 10 seconds each-tandem, semi tandem, and side by side), and the time it takes to sit and stand 5 times in a chair (see above). Scoring is based on a scale of 0-12, lower numbers representing worse performance.	12 months
Secondary	Rate at which exercise will change body composition	With this hypothesis the Investigator will test whether muscle mass (DEXA scan) changes after 6 months and 12 months of an exercise intervention. Baseline measurement will be performed before the intervention, at 6 months and 12 months , with muscle mass measured by DEXA.	12 months
Secondary	Rate at which exercise will change handgrip strength.	With this hypothesis the Investigator will test whether muscle strength (dynamometer) changes after 6 months and 12 months of an exercise intervention. Baseline measurement will be performed before the intervention, at 6 months and 12 months, with strength measured by dynamometer.	12 months
Secondary	Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being.	Participants will be asked about their overall general health using the PROMIS.	12 months
Secondary	Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life.	Participants will be asked about their mental health using SF 36.	12 months
Secondary	Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression.	Participants will be asked about their mental health using the BDI.	12 months
Secondary	Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity.	Participants will be asked about their overall pain intensity using the Numeric Rating Scale for Pain.	12 months