End Stage Renal Failure on DialysisIDEXNCT03944824
The Effect of Intradialytic Exercise on the Physical Function of People Undergoing Hemodialysis
A study testing Exercise Plan using resistance bands and Modified Fried Frailty Scale in people with End Stage Renal Failure on Dialysis and Frail Elderly Syndrome, run by Satellite Healthcare at 1 site in United States.
Trial summary
The investigators intend to recruit 50 patients into an intradialytic exercise study that will measure the impact of resistance bands exercises under the guidance of an exercise physiologist on the physical function of hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis, Frail Elderly Syndrome
- What is being tested?
- Exercise Plan using resistance bands and Modified Fried Frailty Scale
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2019to 17 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or greater
- Ability to understand and communicate English
- Diagnosis of ESRD and currently undergoing in-center hemodialysis
- On HD for longer than 6 weeks
- Approved by the Satellite Milpitas Medical Director and/or referring physician
Who cannot join
- Previous major amputations
- Inability to independently ambulate
- Known to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intradialytic Resistance Exercises Using Resistance Bands With Exercise Physiologist Consultation on the Physical Function of People Undergoing Hemodialysis: a Proof of Concept Study
The investigators intend to recruit 50 patients into an intradialytic exercise study that will measure the impact of resistance bands exercises under the guidance of an exercise physiologist on the physical function of hemodialysis patients.
Read the detailed description
The primary objective of this study will be to test the feasibility and efficacy of a 3 month exercise physiologist consultation program. Specifically, the investigator's aims will be to:
- Test the feasibility of a 3-month exercise physiologist led program
- Measure the effect of an exercise physiologist collaboration and intradialytic exercise on the physical function of HD patients using the 30 second STS test, handgrip strength test [required for frailty scale], 8-foot TUG test and patient physical activity based off of the Low Physical Activity Questionnaire.
- Being tested
- Exercise Plan using resistance bands, Modified Fried Frailty Scale
- Keywords
- Intra-Dialytic Exercise, End Stage Renal Disease, Hemodialysis, Therabands, Exercise Physiologist
- 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.
Exercise Plan using resistance bandsOther
Exercise under the guidance of an exercise physiologist using elastic resistance bands and weekly meeting with an exercise physiologist for 12 weeks
Modified Fried Frailty ScaleDiagnostic test
Patients will be screened for frailty pre and post with sit-to-stand test, timed up and go test, handgrip strength test and administered the low physical activity questionnaire. These components together consist of the Modified Fried Frailty Index.
| Study group | Role | What they receive |
|---|---|---|
| Exercise (Intervention) Arm | Experimental | The 25 patients in this arm will receive an interventional exercise plan using resistance bands and once weekly visits from an exercise physiologist while on dialysis for 12 weeks. They will undergo a frailty screening using a Modified Fried Frailty Scale at the beginning and end of the trial to include: Timed up and Go test, Sit-to-Stand Test, Handgrip Strength Test, Low physical activity questionnaire. Receives: Other: Exercise Plan using resistance bands; Diagnostic Test: Modified Fried Frailty Scale |
| Control | Placebo comparator | The 25 patients in the control arm will not receive an interventional exercise plan or visits from an exercise physiologist while on dialysis for 12 weeks. They will undergo a frailty screening using a Modified Fried Frailty Scale at the beginning and end of the trial to include: Timed up and Go test, Sit-to-Stand Test, Handgrip Strength Test, Low physical activity questionnaire. Receives: Diagnostic Test: Modified Fried Frailty Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Patient Adherence to Exercise Regimen
Adherence calculated as the total number of self-reported exercise sessions attempted by the patient when EP not present divided by the total number of hemodialysis sessions.
Measured: 12 weeks
Rate of Adverse Events Secondary to Exercises
Adverse events defined as any injury, impairment or medical condition that was directly or suspected to be due to performing the prescribed exercise. This information will be collected from the patient at the weekly meeting with the EPs.
Measured: 12 weeks
Secondary outcomes (3)
Change in Sit-To-Stand Test
Change in physical function as measured by the 30 second sit to stand test (STS)
Measured: 12 weeks
Change in Handgrip Strength Test
Change in handgrip strength following the 12 week intervention as measured by a handgrip dynanometer
Measured: 12 weeks
Change in Timed Up and Go Test
Change in 8 foot timed up and go test (TUG).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start22 Feb 2019
- Primary completion10 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure on DialysisStudies 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
- Model description
- The investigators will recruit 25 patients who will receive the exercise plans and once weekly visits from the exercise physiologists. 25 patients will be control. All 50 patients will receive pre and post physical function testing.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944824
- Sponsor's protocol ID
- SH066IDEX
- Acronym
- IDEX
- Status last verified
- Sep 2019
- First submitted
- 12 Feb 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Bao Y, Dalrymple L, Chertow GM, Kaysen GA, Johansen KL. Frailty, dialysis initiation, and mortality in end-stage renal disease. Arch Intern Med. 2012 Jul 23;172(14):1071-7. doi: 10.1001/archinternmed.2012.3020.
PubMed 22733312McAdams-DeMarco MA, Law A, Salter ML, Boyarsky B, Gimenez L, Jaar BG, Walston JD, Segev DL. Frailty as a novel predictor of mortality and hospitalization in individuals of all ages undergoing hemodialysis. J Am Geriatr Soc. 2013 Jun;61(6):896-901. doi: 10.1111/jgs.12266. Epub 2013 May 27.
PubMed 23711111Johansen KL, Delgado C, Kaysen GA, Chertow GM, Chiang J, Dalrymple LS, Segal MR, Grimes BA. Frailty Among Patients Receiving Hemodialysis: Evolution of Components and Associations With Mortality. J Gerontol A Biol Sci Med Sci. 2019 Feb 15;74(3):380-386. doi: 10.1093/gerona/gly206.
PubMed 30192916Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD003236. doi: 10.1002/14651858.CD003236.pub2.
PubMed 21975737Cho JH, Lee JY, Lee S, Park H, Choi SW, Kim JC. Effect of intradialytic exercise on daily physical activity and sleep quality in maintenance hemodialysis patients. Int Urol Nephrol. 2018 Apr;50(4):745-754. doi: 10.1007/s11255-018-1796-y. Epub 2018 Jan 23.
PubMed 29362960Guio BM, Gomes CP, Costa FBD, Oliveira ADS, Duarte MT, Leite M Junior. Beneficial effects of intradialytic cardiopulmonary rehabilitation. J Bras Nefrol. 2017 Jul-Sep;39(3):275-282. doi: 10.5935/0101-2800.20170051. English, Portuguese.
PubMed 29044337Young HML, March DS, Graham-Brown MPM, Jones AW, Curtis F, Grantham CS, Churchward DR, Highton P, Smith AC, Singh SJ, Bridle C, Burton JO. Effects of intradialytic cycling exercise on exercise capacity, quality of life, physical function and cardiovascular measures in adult haemodialysis patients: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018 Aug 1;33(8):1436-1445. doi: 10.1093/ndt/gfy045.
PubMed 29608708Gomes Neto M, de Lacerda FFR, Lopes AA, Martinez BP, Saquetto MB. Intradialytic exercise training modalities on physical functioning and health-related quality of life in patients undergoing maintenance hemodialysis: systematic review and meta-analysis. Clin Rehabil. 2018 Sep;32(9):1189-1202. doi: 10.1177/0269215518760380. Epub 2018 Feb 26.
PubMed 29480025Bennett PN, Fraser S, Barnard R, Haines T, Ockerby C, Street M, Wang WC, Daly R. Effects of an intradialytic resistance training programme on physical function: a prospective stepped-wedge randomized controlled trial. Nephrol Dial Transplant. 2016 Aug;31(8):1302-9. doi: 10.1093/ndt/gfv416. Epub 2015 Dec 28.
PubMed 26715763Anding K, Bar T, Trojniak-Hennig J, Kuchinke S, Krause R, Rost JM, Halle M. A structured exercise programme during haemodialysis for patients with chronic kidney disease: clinical benefit and long-term adherence. BMJ Open. 2015 Aug 27;5(8):e008709. doi: 10.1136/bmjopen-2015-008709.
PubMed 26316654Bennett PN, Peter J, Wang W, Street M. Attitudes of Nephrology Nurses Toward Patient Exercise During Hemodialysis. Nephrol Nurs J. 2016 Jul-Aug;43(4):331-337.
PubMed 30550060Bennett PN, Daly RM, Fraser SF, Haines T, Barnard R, Ockerby C, Kent B. The impact of an exercise physiologist coordinated resistance exercise program on the physical function of people receiving hemodialysis: a stepped wedge randomised control study. BMC Nephrol. 2013 Sep 27;14:204. doi: 10.1186/1471-2369-14-204.
PubMed 24070232Johansen KL, Painter P, Delgado C, Doyle J. Characterization of physical activity and sitting time among patients on hemodialysis using a new physical activity instrument. J Ren Nutr. 2015 Jan;25(1):25-30. doi: 10.1053/j.jrn.2014.06.012. Epub 2014 Sep 8.
PubMed 25213326
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intradialytic Resistance Exercises Using Resistance Bands With Exercise Physiologist Consultation on the Physical Function of People Undergoing Hemodialysis: a Proof of Concept Study
- ClinicalTrials.gov ID
- NCT03944824
- Acronym / sponsor ID
- IDEX / SH066IDEX
- Keywords
- Intra-Dialytic Exercise, End Stage Renal Disease, Hemodialysis, Therabands, Exercise Physiologist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 10 May 2019 (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 investigators intend to recruit 50 patients into an intradialytic exercise study that will measure the impact of resistance bands exercises under the guidance of an exercise physiologist on the physical function of hemodialysis patients.
Detailed description
The primary objective of this study will be to test the feasibility and efficacy of a 3 month exercise physiologist consultation program. Specifically, the investigator's aims will be to:
- Test the feasibility of a 3-month exercise physiologist led program
- Measure the effect of an exercise physiologist collaboration and intradialytic exercise on the physical function of HD patients using the 30 second STS test, handgrip strength test [required for frailty scale], 8-foot TUG test and patient physical activity based off of the Low Physical Activity Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will recruit 25 patients who will receive the exercise plans and once weekly visits from the exercise physiologists. 25 patients will be control. All 50 patients will receive pre and post physical function testing.
| Arm | Type | Receives |
|---|---|---|
| Exercise (Intervention) Arm | Experimental | Other: Exercise Plan using resistance bands, Diagnostic Test: Modified Fried Frailty ScaleThe 25 patients in this arm will receive an interventional exercise plan using resistance bands and once weekly visits from an exercise physiologist while on dialysis for 12 weeks. They will undergo a frailty screening using a Modified Fried Frailty Scale at the beginning and end of the trial to include: Timed up and Go test, Sit-to-Stand Test, Handgrip Strength Test, Low physical activity questionnaire. |
| Control | Placebo comparator | Diagnostic Test: Modified Fried Frailty ScaleThe 25 patients in the control arm will not receive an interventional exercise plan or visits from an exercise physiologist while on dialysis for 12 weeks. They will undergo a frailty screening using a Modified Fried Frailty Scale at the beginning and end of the trial to include: Timed up and Go test, Sit-to-Stand Test, Handgrip Strength Test, Low physical activity questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or greater
- Ability to understand and communicate English
- Diagnosis of ESRD and currently undergoing in-center hemodialysis
- On HD for longer than 6 weeks
- Approved by the Satellite Milpitas Medical Director and/or referring physician
Key exclusion criteria (3 listed)
- Previous major amputations
- Inability to independently ambulate
- Known to be pregnant
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 |
|---|---|---|
| Exercise Plan using resistance bandsExercise under the guidance of an exercise physiologist using elastic resistance bands and weekly meeting with an exercise physiologist for 12 weeks | Other | Exercise (Intervention) Arm |
| Modified Fried Frailty ScalePatients will be screened for frailty pre and post with sit-to-stand test, timed up and go test, handgrip strength test and administered the low physical activity questionnaire. These components together consist of the Modified Fried Frailty Index. | Diagnostic test | Control, Exercise (Intervention) Arm |
Primary outcome
Rate of Patient Adherence to Exercise Regimen
Time frame: 12 weeks
Adherence calculated as the total number of self-reported exercise sessions attempted by the patient when EP not present divided by the total number of hemodialysis sessions.
Rate of Adverse Events Secondary to Exercises
Time frame: 12 weeks
Adverse events defined as any injury, impairment or medical condition that was directly or suspected to be due to performing the prescribed exercise. This information will be collected from the patient at the weekly meeting with the EPs.
3 secondary outcomes
Change in Sit-To-Stand Test
Time frame: 12 weeks
Change in Handgrip Strength Test
Time frame: 12 weeks
Change in Timed Up and Go Test
Time frame: 12 weeks
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 23 Sep 2019.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 22733312Bao Y, Dalrymple L, Chertow GM, Kaysen GA, Johansen KL. Frailty, dialysis initiation, and mortality in end-stage renal disease. Arch Intern Med. 2012 Jul 23;172(14):1071-7. doi: 10.1001/archinternmed.2012.3020.
- Background: PubMed 23711111McAdams-DeMarco MA, Law A, Salter ML, Boyarsky B, Gimenez L, Jaar BG, Walston JD, Segev DL. Frailty as a novel predictor of mortality and hospitalization in individuals of all ages undergoing hemodialysis. J Am Geriatr Soc. 2013 Jun;61(6):896-901. doi: 10.1111/jgs.12266. Epub 2013 May 27.
- Background: PubMed 30192916Johansen KL, Delgado C, Kaysen GA, Chertow GM, Chiang J, Dalrymple LS, Segal MR, Grimes BA. Frailty Among Patients Receiving Hemodialysis: Evolution of Components and Associations With Mortality. J Gerontol A Biol Sci Med Sci. 2019 Feb 15;74(3):380-386. doi: 10.1093/gerona/gly206.
- Background: PubMed 21975737Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD003236. doi: 10.1002/14651858.CD003236.pub2.
- Background: PubMed 29362960Cho JH, Lee JY, Lee S, Park H, Choi SW, Kim JC. Effect of intradialytic exercise on daily physical activity and sleep quality in maintenance hemodialysis patients. Int Urol Nephrol. 2018 Apr;50(4):745-754. doi: 10.1007/s11255-018-1796-y. Epub 2018 Jan 23.
- Background: PubMed 29044337Guio BM, Gomes CP, Costa FBD, Oliveira ADS, Duarte MT, Leite M Junior. Beneficial effects of intradialytic cardiopulmonary rehabilitation. J Bras Nefrol. 2017 Jul-Sep;39(3):275-282. doi: 10.5935/0101-2800.20170051. English, Portuguese.
- Background: PubMed 29608708Young HML, March DS, Graham-Brown MPM, Jones AW, Curtis F, Grantham CS, Churchward DR, Highton P, Smith AC, Singh SJ, Bridle C, Burton JO. Effects of intradialytic cycling exercise on exercise capacity, quality of life, physical function and cardiovascular measures in adult haemodialysis patients: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018 Aug 1;33(8):1436-1445. doi: 10.1093/ndt/gfy045.
- Background: PubMed 29480025Gomes Neto M, de Lacerda FFR, Lopes AA, Martinez BP, Saquetto MB. Intradialytic exercise training modalities on physical functioning and health-related quality of life in patients undergoing maintenance hemodialysis: systematic review and meta-analysis. Clin Rehabil. 2018 Sep;32(9):1189-1202. doi: 10.1177/0269215518760380. Epub 2018 Feb 26.
- Background: PubMed 26715763Bennett PN, Fraser S, Barnard R, Haines T, Ockerby C, Street M, Wang WC, Daly R. Effects of an intradialytic resistance training programme on physical function: a prospective stepped-wedge randomized controlled trial. Nephrol Dial Transplant. 2016 Aug;31(8):1302-9. doi: 10.1093/ndt/gfv416. Epub 2015 Dec 28.
- Background: PubMed 26316654Anding K, Bar T, Trojniak-Hennig J, Kuchinke S, Krause R, Rost JM, Halle M. A structured exercise programme during haemodialysis for patients with chronic kidney disease: clinical benefit and long-term adherence. BMJ Open. 2015 Aug 27;5(8):e008709. doi: 10.1136/bmjopen-2015-008709.
- Background: PubMed 30550060Bennett PN, Peter J, Wang W, Street M. Attitudes of Nephrology Nurses Toward Patient Exercise During Hemodialysis. Nephrol Nurs J. 2016 Jul-Aug;43(4):331-337.
- 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. 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 Exercise Plan using resistance bands and Modified Fried Frailty Scale in people with End Stage Renal Failure on Dialysis and Frail Elderly Syndrome, run by Satellite Healthcare 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 5 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: finished, as of the sponsor's last update on 23 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Rate of Patient Adherence to Exercise Regimen (time frame: 12 weeks). The study lists 2 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 NCT03944824, which also lists 14 linked publications.
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 23 Sep 2019.