ESRDCOMEXNCT03055299
COMEX Study for Dialysis Patients
A study testing COMEX intervention in people with ESRD, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of the COMprehensive EXercise (COMEX) pilot study is to test feasibility, tolerability and adherence of this novel video-based intra-dialytic chair exercise program for hemodialysis patients over 3 months. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ESRD
- What is being tested?
- COMEX intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For patients:
- Age ≥18 years to 85 years
- Undergoing maintenance hemodialysis for >3 months at one of the participating dialysis sites
- Patients must be willing and able to sign the consent form.
- For providers:
- Eligible if they are a registered nurse, dialysis technician, dialysis social worker, dietitian, dialysis unit administrator or nephrologist involved in providing care for one of the patient participants in the study
Who cannot join
- For all patients:
- Uncontrolled BP (>180/100 mm Hg)
- Inadequately dialyzed (Kt/V<1.2)
- History of Intradialytic hypotension (SBP<90mm Hg) or hypertension (SBP>180mmHg) during/post dialysis within last 1 month
- Contraindication to exercise eg unstable angina, uncompensated congestive heart failure
- Refractory/untreated psychiatric disorders
Show all 22Show fewer
- History of poor adherence to HD treatment.
- Scheduled for living donor kidney transplant, intention to change to peritoneal dialysis, home HD, or plans to relocate to another center within the next 6 months.
- Currently in acute or chronic care hospital
- Life expectancy < 6 months or intention to withdraw dialysis therapy within 6 months.
- Current pregnancy, or actively planning to become pregnant in the next 6 months
- Currently a prisoner
- Current use of investigational drugs or participation in another non-observational clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
- Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
- Unable or unwilling to provide informed consent or sign IRB-approved consent form
- Has a tunneled dialysis catheter
- If diabetic, blood sugar control is not stable
- For patients undergoing biopsy and blood draw:
- Allergy to lidocaine
- Anemia, <10.0 Hgb
- Chronic use of oral corticosteroids or other medication that affect muscle function
- Any bleeding disorder that would contraindicate biopsy or blood draw such as a history of clinically significant bleeding diathesis (e.g. hemophilia A or B, Von Willebrand's Disease or congenital Factor VII deficiency)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Comprehensive Exercise (COMEX) Program for Dialysis Patients Pilot Study
The goal of the COMprehensive EXercise (COMEX) pilot study is to test feasibility, tolerability and adherence of this novel video-based intra-dialytic chair exercise program for hemodialysis patients over 3 months.
Read the detailed description
The investigators incorporated patient-provider preferences of the key stakeholders, and used a multi-disciplinary team with experts in physical therapy, psychology and nephrology to develop a comprehensive exercise program for HD patients. Aim of this pilot study is to assess the feasibility, tolerability and adherence to COMEX over 3 months and inform design of future randomized controlled trial. A secondary goal is to explore molecular mechanisms in muscle and blood of exercise adaptation in HD patients
- Conditions
- ESRD
- Being tested
- COMEX intervention
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMEX interventionOther
Comprehensive Exercise
| Study group | Role | What they receive |
|---|---|---|
| COMEX | Experimental | Patients receive comprehensive exercise intervention Receives: Other: COMEX intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Feasibility will be estimated by calculating the % of eligible participants who consent to participate in the study.
Measured: 3 months
Number of participants with exercise-related adverse events
Tolerability will be measured by assessing exercise related side effects - this will be done by weekly patient interviews and review of medical records
Measured: 3 months
Adherence rate
Adherence will be calculated as % of participants who complete the 3 month COMEX intervention. Also, adherence to exercise will be calculated as % of exercise sessions completed
Measured: 3 months
Secondary outcomes (7)
Fatigue
Self reported fatigue using Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Fatigue questionnaire will be measured at baseline and at 3 months
Measured: 3 months
Sleep
Self reported sleep using Pittsburgh Sleep Quality Index (PSQI) questionnaire will be measured at baseline and at 3 months
Measured: 3 months
Depression
Self reported depression using Beck's Depression Inventory -II questionnaire will be measured at baseline and at 3 months
Measured: 3 months
Global health
Self reported HRQOL using NIH Patient Reported Outcomes Measurement Information System (PROMIS) Adult Global Health questionnaire will be measured at baseline and at 3 months
Measured: 3 months
Health related quality of life
Self reported HRQOL using Short-Form 36 questionnaire will be measured at baseline and at 3 months
Measured: 3 months
Sleep/Wake Behavior by Actigraphy
Objective sleep and activity will be measured using actigraphy
Measured: 3 months
Physical functioning
Will be measured by Short Physical Performance battery at baseline and 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start20 Feb 2017
- Primary completion10 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manisha Jhamb, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055299
- Sponsor's protocol ID
- PRO15070086
- Acronym
- COMEX
- Status last verified
- Jul 2018
- First submitted
- 23 Jan 2017
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jhamb M, Devaraj SM, Alemairi M, Lavenburg LM, Shiva S, Yabes JG, Forman DE, Hergenroeder AL. A Comprehensive Exercise (COMEX) Intervention to Optimize Exercise Participation for Improving Patient-Centered Outcomes and Physical Functioning in Patients Receiving Hemodialysis: Development and Pilot Testing. Kidney Med. 2023 Sep 12;5(11):100720. doi: 10.1016/j.xkme.2023.100720. eCollection 2023 Nov.
PubMed 37928754
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Exercise (COMEX) Program for Dialysis Patients Pilot Study
- ClinicalTrials.gov ID
- NCT03055299
- Acronym / sponsor ID
- COMEX / PRO15070086
- Conditions
- ESRD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 16 Feb 2017 (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.
The goal of the COMprehensive EXercise (COMEX) pilot study is to test feasibility, tolerability and adherence of this novel video-based intra-dialytic chair exercise program for hemodialysis patients over 3 months.
Detailed description
The investigators incorporated patient-provider preferences of the key stakeholders, and used a multi-disciplinary team with experts in physical therapy, psychology and nephrology to develop a comprehensive exercise program for HD patients. Aim of this pilot study is to assess the feasibility, tolerability and adherence to COMEX over 3 months and inform design of future randomized controlled trial. A secondary goal is to explore molecular mechanisms in muscle and blood of exercise adaptation in HD patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COMEX | Experimental | Other: COMEX interventionPatients receive comprehensive exercise intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years to 85 years
- Undergoing maintenance hemodialysis for >3 months at one of the participating dialysis sites
- Patients must be willing and able to sign the consent form.
- Eligible if they are a registered nurse, dialysis technician, dialysis social worker, dietitian, dialysis unit administrator or nephrologist involved in providing care for one of the patient participants in the study
Key exclusion criteria (22 listed)
- Uncontrolled BP (>180/100 mm Hg)
- Inadequately dialyzed (Kt/V<1.2)
- History of Intradialytic hypotension (SBP<90mm Hg) or hypertension (SBP>180mmHg) during/post dialysis within last 1 month
- Contraindication to exercise eg unstable angina, uncompensated congestive heart failure
- Refractory/untreated psychiatric disorders
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 |
|---|---|---|
| COMEX interventionComprehensive Exercise | Other | COMEX |
Primary outcome
Recruitment rate
Time frame: 3 months
Feasibility will be estimated by calculating the % of eligible participants who consent to participate in the study.
Number of participants with exercise-related adverse events
Time frame: 3 months
Tolerability will be measured by assessing exercise related side effects - this will be done by weekly patient interviews and review of medical records
Adherence rate
Time frame: 3 months
Adherence will be calculated as % of participants who complete the 3 month COMEX intervention. Also, adherence to exercise will be calculated as % of exercise sessions completed
7 secondary outcomes
Fatigue
Time frame: 3 months
Sleep
Time frame: 3 months
Depression
Time frame: 3 months
Global health
Time frame: 3 months
Health related quality of life
Time frame: 3 months
Sleep/Wake Behavior by Actigraphy
Time frame: 3 months
Physical functioning
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Derived from this study: PubMed 37928754Jhamb M, Devaraj SM, Alemairi M, Lavenburg LM, Shiva S, Yabes JG, Forman DE, Hergenroeder AL. A Comprehensive Exercise (COMEX) Intervention to Optimize Exercise Participation for Improving Patient-Centered Outcomes and Physical Functioning in Patients Receiving Hemodialysis: Development and Pilot Testing. Kidney Med. 2023 Sep 12;5(11):100720. doi: 10.1016/j.xkme.2023.100720. eCollection 2023 Nov.
Related trials for ESRD
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Not yet recruiting
Precision-Medicine Diagnostic Support in Hospitalized Veterans With Acute Kidney Injury
Acute Kidney Injury (AKI)
RecruitingPhase 2
Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Chronic Kidney Disease
Not yet recruitingPhase 2
Ticagrelor for Inflammation and Cardiovascular Risk in Patients With Chronic Kidney Disease
Chronic Kidney Disease (CKD)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMEX intervention in people with ESRD, run by University of Pittsburgh 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 6 inclusion and 22 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: finished, as of the sponsor's last update on 3 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055299, which also lists 1 linked publication.
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 3 Jul 2018.