FrailtyNCT06374537
Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.
A study testing Muscle Therapy in people with Frailty and Pain, Chronic, run by University of Illinois at Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty, Pain, Chronic, Dialysis; Complications
- What is being tested?
- Muscle Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2019to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cardiac/pulmonary disease that contraindicate the physical training
- Unable to give consent
- Unable to travel to the training center
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Ilaria Santi, 312-996-9594, isanti@uic.edu
Natalie Isho, 312-996-4708, nisho@uic.edu
About this study
Official title: Evaluating 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.
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.
- Conditions
- Frailty, Pain, Chronic, Dialysis; Complications, Kidney Diseases
- Being tested
- Muscle Therapy
- Medical subject headings
- Frailty, Chronic Pain, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle TherapyOther
Also called Targeted physical activity, Exercise
Participants will attend 2 muscle therapy sessions a week for 12 months, for one hour each.
| Study group | Role | What they receive |
|---|---|---|
| Investigate the effects of an exercise intervention on clinically debilitated dialysis patients. | Experimental | 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. Receives: Other: Muscle Therapy |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start22 May 2019
- Primary completion22 Apr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Benedetti, University of Illinois at Chicago
- Investigators
- Enrico Benedetti, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374537
- Sponsor's protocol ID
- 2017-0784
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.
- ClinicalTrials.gov ID
- NCT06374537
- Acronym / sponsor ID
- 2017-0784
- Conditions
- Frailty, Pain, Chronic, Dialysis; Complications, Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 22 Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigate the effects of an exercise intervention on clinically debilitated dialysis patients. | Experimental | Other: Muscle Therapy150 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- cardiac/pulmonary disease that contraindicate the physical training
- Unable to give consent
- Unable to travel to the training center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle TherapyAlso: Targeted physical activity, ExerciseParticipants will attend 2 muscle therapy sessions a week for 12 months, for one hour each. | Other | Investigate the effects of an exercise intervention on clinically debilitated dialysis patients. |
Primary outcome
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.
6 secondary outcomes
Rate at which exercise will change body composition
Time frame: 12 months
Rate at which exercise will change handgrip strength.
Time frame: 12 months
Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being.
Time frame: 12 months
Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life.
Time frame: 12 months
Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression.
Time frame: 12 months
Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrico Benedetti principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Therapy in people with Frailty and Pain, Chronic, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Santi (312-996-9594, isanti@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate at which subjects will see changes in their physical abilities. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.