Back to results

The Effect of Exercise on Dialysis Patients' Survival

Primary Purpose

Kidney Disease, Chronic, End Stage Renal Disease, Hemodialysis

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Intradialytic Exercise

About this trial

This is an interventional supportive care trial for Kidney Disease, Chronic focused on measuring mortality, exercise during dialysis, physical function, sarcopenia, hematological parameters

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Dialysis history ≥ 1 year
Without myocardial infarction within past 3 months
Regular dialysis 3 times a week
Ability to consent
Doctor's consent

Exclusion Criteria:

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)

Sites / Locations

Abolfazl medical center
Pardis specialized wellness institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control group

Arm Description

The patients will participate in intradialytic exercise 3 times a week for 24 weeks.

The patients will receive regular care and treatment in every dialysis sessions without any intradialytic exercise.

Outcomes

Primary Outcome Measures

1-year Survival of dialysis patients

Mortality data is gathered using form "CMS-2746" which is specifically for dialysis patients.

Secondary Outcome Measures

Rate of changes of Albumin for 6 months

Rate of changes of Hemoglobin for 6 months

Rate of changes of Hematocrit for 6 months

Rate of changes of Red Blood Cells for 6 months

Rate of changes of Calcium for 6 months

Rate of changes of Phosphorus for 6 months

Rate of changes of Parathyroid Hormone 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

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

Full Information

NCT ID

NCT04898608

First Posted

May 18, 2021

Last Updated

March 27, 2023

Sponsor

Pardis Specialized Wellness Institute

1. Study Identification

Unique Protocol Identification Number

NCT04898608

Brief Title

The Effect of Exercise on Dialysis Patients' Survival

Official Title

The Effect of Intradialytic Exercise on Dialysis Patients' Survival: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

January 25, 2020 (Actual)

Primary Completion Date

August 9, 2021 (Actual)

Study Completion Date

August 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pardis Specialized Wellness Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Disease, Chronic, End Stage Renal Disease, Hemodialysis

Keywords

mortality, exercise during dialysis, physical function, sarcopenia, hematological parameters

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants will be randomly allocate to intervention group or control group and will be examined in the same way.

Masking

Outcomes Assessor

Masking Description

The lab tech will be blind to whether the sample under evaluation belongs to the intervention group or the control group. A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional test. Outcome adjudicators, and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results.

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise group

Arm Type

Experimental

Arm Description

The patients will participate in intradialytic exercise 3 times a week for 24 weeks.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

The patients will receive regular care and treatment in every dialysis sessions without any intradialytic exercise.

Intervention Type

Other

Intervention Name(s)

Intradialytic Exercise

Intervention Description

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.

Primary Outcome Measure Information:

Title

1-year Survival of dialysis patients

Description

Mortality data is gathered using form "CMS-2746" which is specifically for dialysis patients.

Time Frame

Follow-up phase (1- year)

Secondary Outcome Measure Information:

Title

Rate of changes of Albumin for 6 months

Time Frame