Kidney Disease, ChronicNCT04898608
The Effect of Exercise on Dialysis Patients' Survival
A study testing Intradialytic Exercise in people with Kidney Disease, Chronic and End Stage Renal Disease, run by Pardis Specialized Wellness Institute at 2 sites in Iran.
Trial summary
The purpose of this study is to check if patients' exercise during their dialysis sessions can prevent their early deaths. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Disease, Chronic, End Stage Renal Disease, Hemodialysis
- What is being tested?
- Intradialytic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesIran
- Study dates
- 25 Jan 2020to 9 Aug 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis history ≥ 1 year
- Without myocardial infarction within past 3 months
- Regular dialysis 3 times a week
- Ability to consent
- Doctor's consent
Who cannot join
- Unstable cardiac status (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias, etc.)
- Active infection or acute medical illness
- Hemodynamic instability
- Labile glycemic control
- Unable to exercise (lower extremity amputation with no prosthesis)
- having severe musculoskeletal pain at rest or with minimal activity
- Unable to sit, stand or walk unassisted (walking device such as cane or walker allowed)
- Having shortness of breath at rest or with activities of daily living (NYHA Class IV)
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Abolfazl medical center
Isfahan, 813991447
Pardis specialized wellness institute
Isfahan
About this study
Official title: The Effect of Intradialytic Exercise on Dialysis Patients' Survival: A Randomized Controlled Trial
The purpose of this study is to check if patients' exercise during their dialysis sessions can prevent their early deaths.
Read the detailed description
Dialysis patients suffer from a number of problems, one of which is reduced ability, decreased functional capacity, and consequently reduced physical capability. Forced inactivity due to immobility in dialysis sessions and the need to rest and relieve fatigue for a few hours after each session cause patients to become more inactive day by day, and according to various studies, inactivity in these patients along with reduced physical capabilities increase the risk of cardiovascular disease, which is a risk factor for mortality in these patients.
On the other hand, inactivity is an independent predictor of hospitalization and mortality in these patients.
Studies have shown that exercise can produce many different effects in these patients. However, exercise interventions are often short-term, and even in long-term cases, the aim of studies is only to examine a number of hematological factors or factors such as functional capacity in these patients.
A study is currently being designed to directly evaluate the impact of exercise on patients' survival.
To test this hypothesis, patients do exercise for 6 months during dialysis. And then will be monitored for a year to determine patients' survival.
During 6 months of intervention, hematological parameters, nutrition index and functional capacity of patients are evaluated.
In the analyzes, the survival rate of patients in one year follow-up period is compared between patients who took part in intradialytic sessions (intervention group) and patients who did not do any physical activity during dialysis (control group). In addition, by analyzing the variables measured during the 6 months of the intervention, the effect of exercise on parameters relating to survival is evaluated.
- Being tested
- Intradialytic Exercise
- Keywords
- mortality, exercise during dialysis, physical function, sarcopenia, hematological parameters
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic ExerciseOther
Participants will do concurrent exercise (a combination of aerobic exercise and resistance training) for 30-60 minutes during the second hour of their routine hemodialysis sessions.
To determine the intensity of the prescribed exercise, maximum heart rate is used for aerobic workout and 1RM for resistance protocols.
Exercises will be performed at a moderate exercise intensity (12-14 on the Borg RPE Scale).
All protocols are tailor-made based on each individual's needs and physical abilities.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The patients will participate in intradialytic exercise 3 times a week for 24 weeks. Receives: Other: Intradialytic Exercise |
| Control group | No intervention | The patients will receive regular care and treatment in every dialysis sessions without any intradialytic exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Survival of dialysis patients
Mortality data is gathered using form "CMS-2746" which is specifically for dialysis patients.
Measured: Follow-up phase (1- year)
Secondary outcomes (9)
Rate of changes of Albumin for 6 months
Measured: Pre_test and every 3 months for 6 months
Rate of changes of Hemoglobin for 6 months
Measured: Pre_test and every 3 months for 6 months
Rate of changes of Hematocrit for 6 months
Measured: Pre_test and every 3 months for 6 months
Rate of changes of Red Blood Cells for 6 months
Measured: Pre_test and every 3 months for 6 months
Rate of changes of Calcium for 6 months
Measured: Pre_test and every 3 months for 6 months
Rate of changes of Phosphorus for 6 months
Measured: Pre_test and every 3 months for 6 months
Rate of changes of Parathyroid Hormone for 6 months
Measured: Pre_test and every 3 months for 6 months
Changes of GNRI for 6 months
The Geriatric Nutritional Risk Index (GNRI) is a screening method that was primarily developed to identify older patients with malnutrition. It consists of serum albumin levels as well as body weight measurements. GNRI is associated with an increasing risk of long-term all-cause mortality in prevalent hemodialysis patients, even after adjusting for age and comorbidity
Measured: Pre_test and every 3 months for 6 months
Changes of the meters walked during the 6MWT for 6 months
Six-minute walk test (6MWT) is a walking endurance assessment measured in meters of total distance completed over 6 minutes
Measured: Pre_test and every 3 months for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start25 Jan 2020
- Primary completion9 Aug 2021
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Kidney Disease, ChronicStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pardis Specialized Wellness Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Ali Tabibi, Dr, Principal investigator, Pardis Specialized Wellness Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898608
- Sponsor's protocol ID
- PA20HD-2-01
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.
Publications
Xiong J, Wang M, Zhang Y, Nie L, He T, Wang Y, Huang Y, Feng B, Zhang J, Zhao J. Association of Geriatric Nutritional Risk Index with Mortality in Hemodialysis Patients: A Meta-Analysis of Cohort Studies. Kidney Blood Press Res. 2018;43(6):1878-1889. doi: 10.1159/000495999. Epub 2018 Dec 14.
PubMed 30566933Tabibi MA, Ahmadi E, Nasrin S. POS-621 The effect of concurent exercise during dialysis on hemoglobin,red blood cells and hematocrit in hemodialysis patients. Kidney International Reports. 2021; 6(4): 270-271. doi: 10.1016/j.ekir.2021.03.650
Shimoda T, Matsuzawa R, Yoneki K, Harada M, Watanabe T, Matsumoto M, Yoshida A, Takeuchi Y, Matsunaga A. Changes in physical activity and risk of all-cause mortality in patients on maintence hemodialysis: a retrospective cohort study. BMC Nephrol. 2017 May 8;18(1):154. doi: 10.1186/s12882-017-0569-7.
PubMed 28482880Bakaloudi DR, Siargkas A, Poulia KA, Dounousi E, Chourdakis M. The Effect of Exercise on Nutritional Status and Body Composition in Hemodialysis: A Systematic Review. Nutrients. 2020 Oct 8;12(10):3071. doi: 10.3390/nu12103071.
PubMed 33050111Parker K. Intradialytic Exercise is Medicine for Hemodialysis Patients. Curr Sports Med Rep. 2016 Jul-Aug;15(4):269-75. doi: 10.1249/JSR.0000000000000280.
PubMed 27399824K/DOQI Workgroup. K/DOQI clinical practice guidelines for cardiovascular disease in dialysis patients. Am J Kidney Dis. 2005 Apr;45(4 Suppl 3):S1-153. No abstract available.
PubMed 15806502Milam RH. Exercise Guidelines for Chronic Kidney Disease Patients. J Ren Nutr. 2016 Jul;26(4):e23-5. doi: 10.1053/j.jrn.2016.03.001. No abstract available.
PubMed 27318109Scapini KB, Bohlke M, Moraes OA, Rodrigues CG, Inacio JF, Sbruzzi G, Leguisamo CP, Sanches IC, Tourinho Filho H, Irigoyen MC. Combined training is the most effective training modality to improve aerobic capacity and blood pressure control in people requiring haemodialysis for end-stage renal disease: systematic review and network meta-analysis. J Physiother. 2019 Jan;65(1):4-15. doi: 10.1016/j.jphys.2018.11.008. Epub 2018 Dec 21.
PubMed 30581137Huang M, Lv A, Wang J, Xu N, Ma G, Zhai Z, Zhang B, Gao J, Ni C. Exercise Training and Outcomes in Hemodialysis Patients: Systematic Review and Meta-Analysis. Am J Nephrol. 2019;50(4):240-254. doi: 10.1159/000502447. Epub 2019 Aug 27.
PubMed 31454822Pu J, Jiang Z, Wu W, Li L, Zhang L, Li Y, Liu Q, Ou S. Efficacy and safety of intradialytic exercise in haemodialysis patients: a systematic review and meta-analysis. BMJ Open. 2019 Jan 21;9(1):e020633. doi: 10.1136/bmjopen-2017-020633.
PubMed 30670499Zhang F, Zhou W, Sun Q, Zhai Y, Zhang Y, Su H, Wang Z. Effects of intradialytic resistance exercises on physical performance, nutrient intake and quality of life among haemodialysis people: A systematic review and meta-analysis. Nurs Open. 2021 Mar;8(2):529-538. doi: 10.1002/nop2.274. Epub 2019 Sep 30.
PubMed 33570280Noordzij M, Korevaar JC, Boeschoten EW, Dekker FW, Bos WJ, Krediet RT; Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD) Study Group. The Kidney Disease Outcomes Quality Initiative (K/DOQI) Guideline for Bone Metabolism and Disease in CKD: association with mortality in dialysis patients. Am J Kidney Dis. 2005 Nov;46(5):925-32. doi: 10.1053/j.ajkd.2005.08.013.
PubMed 16253734Stevens LA, Djurdjev O, Cardew S, Cameron EC, Levin A. Calcium, phosphate, and parathyroid hormone levels in combination and as a function of dialysis duration predict mortality: evidence for the complexity of the association between mineral metabolism and outcomes. J Am Soc Nephrol. 2004 Mar;15(3):770-9. doi: 10.1097/01.asn.0000113243.24155.2f.
PubMed 14978180Pifer TB, McCullough KP, Port FK, Goodkin DA, Maroni BJ, Held PJ, Young EW. Mortality risk in hemodialysis patients and changes in nutritional indicators: DOPPS. Kidney Int. 2002 Dec;62(6):2238-45. doi: 10.1046/j.1523-1755.2002.00658.x.
PubMed 12427151Avram MM, Blaustein D, Fein PA, Goel N, Chattopadhyay J, Mittman N. Hemoglobin predicts long-term survival in dialysis patients: a 15-year single-center longitudinal study and a correlation trend between prealbumin and hemoglobin. Kidney Int Suppl. 2003 Nov;(87):S6-11. doi: 10.1046/j.1523-1755.64.s87.3.x.
PubMed 14531767
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intradialytic Exercise on Dialysis Patients' Survival: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04898608
- Acronym / sponsor ID
- PA20HD-2-01
- Keywords
- mortality, exercise during dialysis, physical function, sarcopenia, hematological parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Pardis Specialized Wellness InstituteUniversity, hospital or other
- Study start
- 25 Jan 2020 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 24 May 2021 (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 purpose of this study is to check if patients' exercise during their dialysis sessions can prevent their early deaths.
Detailed description
Dialysis patients suffer from a number of problems, one of which is reduced ability, decreased functional capacity, and consequently reduced physical capability. Forced inactivity due to immobility in dialysis sessions and the need to rest and relieve fatigue for a few hours after each session cause patients to become more inactive day by day, and according to various studies, inactivity in these patients along with reduced physical capabilities increase the risk of cardiovascular disease, which is a risk factor for mortality in these patients.
On the other hand, inactivity is an independent predictor of hospitalization and mortality in these patients.
Studies have shown that exercise can produce many different effects in these patients. However, exercise interventions are often short-term, and even in long-term cases, the aim of studies is only to examine a number of hematological factors or factors such as functional capacity in these patients.
A study is currently being designed to directly evaluate the impact of exercise on patients' survival.
To test this hypothesis, patients do exercise for 6 months during dialysis. And then will be monitored for a year to determine patients' survival.
During 6 months of intervention, hematological parameters, nutrition index and functional capacity of patients are evaluated.
In the analyzes, the survival rate of patients in one year follow-up period is compared between patients who took part in intradialytic sessions (intervention group) and patients who did not do any physical activity during dialysis (control group). In addition, by analyzing the variables measured during the 6 months of the intervention, the effect of exercise on parameters relating to survival is evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Intradialytic ExerciseThe patients will participate in intradialytic exercise 3 times a week for 24 weeks. |
| Control group | No intervention | –The patients will receive regular care and treatment in every dialysis sessions without any intradialytic exercise. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dialysis history ≥ 1 year
- Without myocardial infarction within past 3 months
- Regular dialysis 3 times a week
- Ability to consent
- Doctor's consent
Key exclusion criteria (8 listed)
- Unstable cardiac status (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias, etc.)
- Active infection or acute medical illness
- Hemodynamic instability
- Labile glycemic control
- Unable to exercise (lower extremity amputation with no prosthesis)
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 |
|---|---|---|
| Intradialytic ExerciseParticipants will do concurrent exercise (a combination of aerobic exercise and resistance training) for 30-60 minutes during the second hour of their routine hemodialysis sessions. To determine the intensity of the prescribed exercise, maximum heart rate is used for aerobic workout and 1RM for resistance protocols. Exercises will be performed at a moderate exercise intensity (12-14 on the Borg RPE Scale). All protocols are tailor-made based on each individual's needs and physical abilities. | Other | Exercise group |
Primary outcome
1-year Survival of dialysis patients
Time frame: Follow-up phase (1- year)
Mortality data is gathered using form "CMS-2746" which is specifically for dialysis patients.
9 secondary outcomes
Rate of changes of Albumin for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Hemoglobin for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Hematocrit for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Red Blood Cells for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Calcium for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Phosphorus for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Parathyroid Hormone for 6 months
Time frame: Pre_test and every 3 months for 6 months
Changes of GNRI for 6 months
Time frame: Pre_test and every 3 months for 6 months
Changes of the meters walked during the 6MWT for 6 months
Time frame: Pre_test and every 3 months for 6 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 28 Mar 2023.
- Background: PubMed 30566933Xiong J, Wang M, Zhang Y, Nie L, He T, Wang Y, Huang Y, Feng B, Zhang J, Zhao J. Association of Geriatric Nutritional Risk Index with Mortality in Hemodialysis Patients: A Meta-Analysis of Cohort Studies. Kidney Blood Press Res. 2018;43(6):1878-1889. doi: 10.1159/000495999. Epub 2018 Dec 14.
- BackgroundTabibi MA, Ahmadi E, Nasrin S. POS-621 The effect of concurent exercise during dialysis on hemoglobin,red blood cells and hematocrit in hemodialysis patients. Kidney International Reports. 2021; 6(4): 270-271. doi: 10.1016/j.ekir.2021.03.650
- Background: PubMed 28482880Shimoda T, Matsuzawa R, Yoneki K, Harada M, Watanabe T, Matsumoto M, Yoshida A, Takeuchi Y, Matsunaga A. Changes in physical activity and risk of all-cause mortality in patients on maintence hemodialysis: a retrospective cohort study. BMC Nephrol. 2017 May 8;18(1):154. doi: 10.1186/s12882-017-0569-7.
- Background: PubMed 33050111Bakaloudi DR, Siargkas A, Poulia KA, Dounousi E, Chourdakis M. The Effect of Exercise on Nutritional Status and Body Composition in Hemodialysis: A Systematic Review. Nutrients. 2020 Oct 8;12(10):3071. doi: 10.3390/nu12103071.
- Background: PubMed 27399824Parker K. Intradialytic Exercise is Medicine for Hemodialysis Patients. Curr Sports Med Rep. 2016 Jul-Aug;15(4):269-75. doi: 10.1249/JSR.0000000000000280.
- Background: PubMed 15806502K/DOQI Workgroup. K/DOQI clinical practice guidelines for cardiovascular disease in dialysis patients. Am J Kidney Dis. 2005 Apr;45(4 Suppl 3):S1-153. No abstract available.
- Background: PubMed 27318109Milam RH. Exercise Guidelines for Chronic Kidney Disease Patients. J Ren Nutr. 2016 Jul;26(4):e23-5. doi: 10.1053/j.jrn.2016.03.001. No abstract available.
- Background: PubMed 30581137Scapini KB, Bohlke M, Moraes OA, Rodrigues CG, Inacio JF, Sbruzzi G, Leguisamo CP, Sanches IC, Tourinho Filho H, Irigoyen MC. Combined training is the most effective training modality to improve aerobic capacity and blood pressure control in people requiring haemodialysis for end-stage renal disease: systematic review and network meta-analysis. J Physiother. 2019 Jan;65(1):4-15. doi: 10.1016/j.jphys.2018.11.008. Epub 2018 Dec 21.
- Background: PubMed 31454822Huang M, Lv A, Wang J, Xu N, Ma G, Zhai Z, Zhang B, Gao J, Ni C. Exercise Training and Outcomes in Hemodialysis Patients: Systematic Review and Meta-Analysis. Am J Nephrol. 2019;50(4):240-254. doi: 10.1159/000502447. Epub 2019 Aug 27.
- Background: PubMed 30670499Pu J, Jiang Z, Wu W, Li L, Zhang L, Li Y, Liu Q, Ou S. Efficacy and safety of intradialytic exercise in haemodialysis patients: a systematic review and meta-analysis. BMJ Open. 2019 Jan 21;9(1):e020633. doi: 10.1136/bmjopen-2017-020633.
- Background: PubMed 33570280Zhang F, Zhou W, Sun Q, Zhai Y, Zhang Y, Su H, Wang Z. Effects of intradialytic resistance exercises on physical performance, nutrient intake and quality of life among haemodialysis people: A systematic review and meta-analysis. Nurs Open. 2021 Mar;8(2):529-538. doi: 10.1002/nop2.274. Epub 2019 Sep 30.
- Background: PubMed 16253734Noordzij M, Korevaar JC, Boeschoten EW, Dekker FW, Bos WJ, Krediet RT; Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD) Study Group. The Kidney Disease Outcomes Quality Initiative (K/DOQI) Guideline for Bone Metabolism and Disease in CKD: association with mortality in dialysis patients. Am J Kidney Dis. 2005 Nov;46(5):925-32. doi: 10.1053/j.ajkd.2005.08.013.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.
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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.
Mohammad Ali Tabibi, Dr principal investigator
Pardis Specialized Wellness Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic Exercise in people with Kidney Disease, Chronic and End Stage Renal Disease, run by Pardis Specialized Wellness Institute at 2 sites in Iran.
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 8 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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?
1-year Survival of dialysis patients (time frame: Follow-up phase (1- year)). 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 NCT04898608, which also lists 23 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 28 Mar 2023.