Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension

October 15, 2022 updated by: Clara Bohm, University of Manitoba

Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension: a Randomized Crossover Study

The objective of this study is to compare the rate of low blood pressure events (Intradialytic Hypotension: IDH) when intradialytic exercise is performed in the first half of the hemodialysis (HD) session as compared to that when intradialytic exercise is performed in the second half of the HD session. The investigators expect that there will be little to no difference in occurrence of IDH episodes between the two time periods based on the experience of the 3 centres and imaging studies of the heart with exercise in HD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intradialytic hypotension (IDH) is a common complication during hemodialysis, occurring in 20-30% of HD treatments. IDH can cause unpleasant symptoms and lead to decline in residual kidney function, vascular access thrombosis, ischemic damage to white matter of the brain, volume overload, increased risk of cardiovascular events and increased mortality risk.

Intradialytic exercise has been shown to improve physical function, health-related quality of life and cardiac function. Initial concerns regarding the potential for intradialytic exercise to increase the rate of IDH have been mitigated by multiple interventional studies in which intradialytic exercise has been shown to be safe with minimal adverse effects. However, concerns regarding the potential of intradialytic exercise to increase frequency of IDH if exercise is performed in second half of HD remain.

No study has specifically compared the frequency IDH episodes when exercise is performed during second half of HD as compared to that when exercise is performed during the first half of a HD session to fully characterize the effect of timing of intradialytic exercise and its effect on IDH.

The investigators aim to address this knowledge gap with a crossover study examining the rate of IDH when individuals in a clinical intradialytic cycling program exercise during the first half of their hemodialysis session as compared with the IDH rate when exercise is performed during the second half of hemodialysis.

To facilitate study implementation and optimize use of exercise resources and equipment, participants at each site will be randomly split into 2 groups. Group 1 will perform 2 weeks of their usual intradialytic cycling (6 sessions) during the first half of their usual HD and then perform 2 weeks of intradialytic cycling (6 sessions) during the second half of their usual HD. Group 2 will perform the intervention in reverse order to Group 1. No washout period is required as there is no biological plausibility for carry over effect. However, as participation in the cycling program is voluntary, some participants choose not to exercise during some of their HD sessions. The investigators will monitor these non-cycling sessions for IDH as well and will compare IDH rate in these non-exercise sessions with IDH rate during sessions when intradialytic exercise was performed, if numbers allow.

Participants will perform their usual duration and intensity of intradialytic cycling at each HD session as per standard clinical intradialytic cycling protocol procedures in each unit. Prescribed exercise time and intensity will remain unchanged over the course of the study.

The investigators will attempt to keep dialysate composition, dialyzer, dialysate temperature, HD access, dialysis duration and medications unchanged over the course of the study, but will not intervene/interfere with usual clinical care. The research assistant will record any changes to dialysis prescription related to routine clinical care on a weekly basis.

Baseline demographic and clinical data will be collected from the hemodialysis chart. This will include age, sex, race, time on hemodialysis, hemodialysis access, dialysis vintage, comorbidities (including hypertension, diabetes, congestive heart failure and ischemic heart disease), amount of fluid removed at each HD, hemoglobin, Kt/V (dialysis efficacy), medications and blood work results as measured on last monthly bloodwork.

The investigators will use the initial BP measurement obtained once the patient has commenced HD (i.e. patient "hooked up" and blood present in both venous and arterial lines) for the baseline BP. Blood pressure (BP) will be measured as per routine procedures used in the participants' HD units (usual arm/leg, usual BP cuff). Pre and post HD BP will be collected as per usual HD Unit practice. During HD, BP will be collected more frequently than the usual routine (q30 min) at q15min intervals or more frequently when clinically indicated based on patient symptoms or status. This timing will be pre-programmed into HD machines to minimize work for bedside HD nurses. However, bedside HD nurses will need to record each measurement on the HD run sheet.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary Cumming School of Medicine Department of Internal Medicine
      • Edmonton, Alberta, Canada, T6G 2G3
        • University of Alberta Department of Internal Medicine
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • University of Manitoba Department of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult (>= 18 years old), receiving three times per week chronic in-centre hemodialysis, current active participant in clinical intradialytic cycling program offered at each study site, able to communicate in English, able to provide written consent

Exclusion Criteria:

  • dialysis frequency not three times per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Early Intradialytic Exercise
Intradialytic cycling will occur in the first half of hemodialysis treatment
Other: Early Intradialytic Exercise
Timing of intradialytic exercise first half of HD
EXPERIMENTAL: Late Intradialytic Exercise
Intradialytic cycling will occur in the second half of hemodialysis treatment
Other: Late Intradialytic Exercise
Timing of intradialytic exercise second half of HD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the rate of IDH (episodes of hypotension per 100 hours of HD) between the 2 study time periods (early and late intradialytic exercise)
Time Frame: 4 weeks
IDH will be defined as a composite of >= 20 mmHg drop from baseline bp or a drop in systolic BP to <90 mmHg
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in rate of IDH (episodes of hypotension per 100 hours of HD) between the 2 study time periods AND associated symptoms OR requiring intervention by bedside nurse
Time Frame: 4 weeks
IDH as defined by a >20 mmHg drop from baseline BP. IDH associated symptoms as follows: abdominal discomfort, yawning, sighing, nausea, vomiting, muscle cramps, restlessness, dizziness or fainting, and anxiety
4 weeks
Difference in frequency and severity of dialysis-related symptoms as measured by the Dialysis Symptom Index between exercise performed in the first and second half of HD sessions.
Time Frame: 4 weeks
Frequency and severity of symptoms will be measured using the symptom burden score as measured by the Dialysis Symptom Index (DSI). The DSI is a 30-item self-administered questionnaire with low administrative burden that measures the presence (yes/no) and severity (5 point Likert-scale) of common symptoms in HD patients (cramping, nausea, dizziness, fatigue, chest pain and shortness of breath) and has been shown to be reliable and valid. Participants will complete the DSI at time of consent and then weekly at the end of the midweek HD session for the duration of the study
4 weeks
Difference in time for recovery post-dialysis between the 2 study time periods (early and late intradialytic exercise)
Time Frame: 4 weeks
Participants will be asked to answer the question "Approximately how much time does it take to recover from a dialysis session?" at each study assessment. Answers will be recorded in minutes.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

University of Alberta
University of Calgary

Investigators

  • Principal Investigator: Jennifer MacRae, MD,MSc, University of Calgary
  • Principal Investigator: Stephanie Thompson, MD, PhD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 9, 2018

Primary Completion (ACTUAL)

April 30, 2019

Study Completion (ACTUAL)

April 30, 2019

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (ACTUAL)

April 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 15, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS21703 (B2018:035)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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