ClinicalTrials.gg
RecruitingNCT06374537Updated Sep 8, 2026

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

An interventional study of Muscle Therapy in Frailty, Pain, Chronic and Dialysis; Complications, sponsored by University of Illinois at Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 10 months after the study started (first participant enrolled May 2019, registered Apr 2024).
  • Started May 2019; still recruiting 7 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 185 studies in Frailty with a site in United States — 50 open to participants now, 62 under way, 1 of them phase 3. Frailty · United States.

Planned enrollment
17th of 142
150 · median 42
Started
2019
with 12 others
No phase
93 of 185
29 open now
Primary completion
2027-04
later than 38 of 60 live
Registered
159th of 185
by date

Among the 185 studies in Frailty with a site in United States, this one is the 17th largest by planned enrollment of the 142 interventional ones, is one of 13 that started in 2019, is one of 93 with no phase, reaches primary completion later than 38 of the 60 other live ones, and was the 159th registered.

By phase

185 studies; the count open now beside each. This study's row is marked.

No phasethis study93 · 29 open
Observational42 · 10 open
Phase 224 · 5 open
Phase 18 · 3 open
Phase 1/28 · 2 open
Phase 35 · 1 open
Phase 45 · 0 open

By the year they started

First in 2001; this study’s year is marked. 13 started in 2019.

Size and results

Median enrollment 42 across the 142 interventional studies, 128 across the 42 observational. Of the 112 that completed or were terminated, 42 (38%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 185 studies in Frailty with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed 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.

03

Conditions studied

  • Frailty
  • Pain, Chronic
  • Dialysis; Complications
  • Kidney Diseases
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinically debilitated patients, currently on dialysis, or have CKD 4 ( 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

Exclusion Criteria:

  • cardiac/pulmonary disease that contraindicate the physical training
  • Unable to give consent
  • Unable to travel to the training center
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Investigate the effects of an exercise intervention on clinically debilitated dialysis patients.

    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. After the initial baseline visit, subjects will come twice weekly, for roughly 1 hour each session, for 12 months (96 visits total). Subjects will also come in for data collection visits at baseline (prior to starting the exercise program), 6 months, and 12 months. Each of those visits will take about 2-3 hours. All testing done in the 3 test visits will help assess the patient's cardiovascular and functional responses and/or changes to the exercise intervention.

    Other: Muscle Therapy

  • No intervention
    Control

    The control arm will receive no exercise intervention. Subjects will also come in for data collection visits at baseline (prior to starting the exercise program), 6 months, and 12 months. Each of those visits will take about 2-3 hours. All testing done in the 3 test visits will help assess the patient's cardiovascular and functional responses.

Interventions

  • OtherMuscle Therapy

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

    Also known as: Targeted physical activity, Exercise

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. 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.

    Time frame: 12 months

  4. 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.

    Time frame: 12 months

  5. 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.

    Time frame: 12 months

  6. 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.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2019 (actual). Primary completion is estimated for Apr 2027, 95 months after the start.

Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 95 months is above that.

Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2024
First posted
Apr 18, 2024
StartActual
May 22, 2019
Primary completionEst.
Apr 22, 2027
CompletionEst.
May 2027
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06374537
Responsible party
Enrico Benedetti (MD, Professor and Head Department of Surgery, University of Illinois at Chicago) — Principal investigator
First posted
Apr 18, 2024
Start date
May 22, 2019
Primary completion
Apr 22, 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Ilaria Santi
Contact
isanti@uic.edu
312-996-9594
Natalie Isho
Contact
nisho@uic.edu
312-996-4708
Enrico Benedetti
principal investigator · University of Illinois at Chicago

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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