Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06374537

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Frailty Chronic Pain Dialysis; Complications Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neurologic Manifestations Pain Pain, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscle Therapy

Other

Participants will attend 2 muscle therapy sessions a week for 12 months, for one hour each.

Other names: Targeted physical activity, Exercise

Primary outcomes

  1. Rate at which subjects will see changes in their physical abilities.

    Time frame: 12 months

    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.

Secondary outcomes

  1. Rate at which exercise will change body composition

    Time frame: 12 months

    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.

  2. Rate at which exercise will change handgrip strength.

    Time frame: 12 months

    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.

  3. Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being.

    Time frame: 12 months

    Participants will be asked about their overall general health using the PROMIS.

  4. Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life.

    Time frame: 12 months

    Participants will be asked about their mental health using SF 36.

  5. Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression.

    Time frame: 12 months

    Participants will be asked about their mental health using the BDI.

  6. Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity.

    Time frame: 12 months

    Participants will be asked about their overall pain intensity using the Numeric Rating Scale for Pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilaria Santi

CONTACT

[email protected]

312-996-9594

Natalie Isho

CONTACT

[email protected]

312-996-4708

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Apr 18, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.