The Feasibility and Safety of an Intradialytic Exercise Program: DIALY-SIZE

NCT02234232 | Completed

• 2 other identifiers: RES0016810RES0018218
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this pilot study is to evaluate the feasibility and safety of four different types of intradialytic exercise (exercise performed during dialysis) programs: resistance, aerobic, combined resistance and aerobic, and flexibility (attention control). The secondary aim of the study is to estimate the effect of aerobic and resistance exercise, each compared with the attention control on: health-related quality of life, tests of physical performance, strength, and physical activity outside of the dialysis unit. The results of this study will be used to inform the planning of a full-scale efficacy study.

Conditions

End-stage Renal Disease

Keywords

Hemodialysis; Exercise, aerobic; Exercise, resistance; Intradialytic; Randomized Controlled Trial; Safety; Quality of life; Physical performance

Outcome Measures

Primary Outcomes (6)

• The number of participants with an adverse event

  among each of the intervention groups, the number of participants with and type of adverse events will be compared to control. Adverse events are defined a priori and classified as either i. Serious adverse events (cardiac event e.g. arrhythmia, myocardial infarction; death; hospitalization; disability; any life threatening event) or ii. Adverse events (musculoskeletal injury; hypoglycemia; hypotension, defined as a decrease in systolic blood pressure by ≥20 mm Hg with symptoms or requiring an intervention during exercise; hypertension, define as a sustained elevation in blood pressure of \>200 mmHg systolic or \>110 diastolic; dialysis access complications (e.g. re-needling, hematosis, thrombosis); and any staff intervention beyond minimum ultrafiltration.

  Change from baseline to 12 weeks

• Adherence to the exercise protocol

  To indicate the willingness of participants to engage in intradialytic exercise, adherence will be reported as the proportion of exercise sessions that were initiated out of the total number of sessions prescribed (defined as ≥ 70% of exercise sessions). To measure the amount of exercise that was actually performed, adherence will be defined as the number of sessions that were completed out of the total number of sessions prescribed (defined as ≥ 70% of exercise sessions). Adherence will be reported according to randomization groups.

  At 12 weeks

• The number of dropouts

  A dropout is defined as a participant who leaves the study for any reason prior to completing the 12-week (36 session) exercise program. All reasons for drop out will be reported.

  At the end of the study, 6 months

• Human activity profile

  To evaluate if an exercise program would influence the level of daily physical activity in this population, the difference in the amount of daily physical activity performed outside of the HD unit at baseline and at 12 weeks will be measured.

  Change from baseline to 12 weeks

• The number of participants who adopted the other group's exercise

  Due the open nature of the dialysis unit, participants are aware of other participant's exercise assignments. To measure the effect of contamination, we will obtain this information from participants at the end of the study through an anonymized questionnaire.

  Change from baseline and 12 weeks

• The proportion of patients that would continue their current intradialytic exercise program after the study is over.

  Defined as ≥50% of participants reporting that they would like to continue their current intradialytic exercise program after the study is over. This information will be collected at the end of the study using an anonymized questionnaire

  At the end of the study, 6 months.

Secondary Outcomes (5)

• Health-related quality of life

  Change from baseline to 12 weeks

• Physical performance

  Change from baseline to 12 weeks

• The six minute walk test

  Change from baseline to 12 weeks

• Number of chair stands completed in 30 seconds

  Change from baseline to 12 weeks

• Strength, one repetition maximum

  Change from baseline to 12 weeks

Other Outcomes (1)

• Physical performance

  Pre/post (12 weeks)

Study Arms (4)

Aerobic exercise

EXPERIMENTAL

Cycling-participants will exercise for 15 minutes at the initial session followed by a weekly increase of 2 min and 3 seconds over 12 weeks. Participants will exercise 3 times per week and an intensity of "somewhat hard" (12-14 on the Borg scale). All exercises will be performed during hemodialysis.

Behavioral: Exercise

Resistance

EXPERIMENTAL

Resistance training of lower limbs using ankle weights. Participants will complete 10-15 repetitions of 4 lower limb exercises: knee extension, straight leg raise, hip abduction, and hip flexion. Exercises will progress from 1 set of each exercise up to 3 sets of each exercise and with weight. Participants will exercise 3 times per week and an intensity of "somewhat hard" (12-14 on the Borg scale). All exercises will be performed during hemodialysis.

Behavioral: Exercise

Combined aerobic and resistance

EXPERIMENTAL

Participants will complete both the aerobic (cycling) and resistance (ankle weights) exercise prescriptions.

Behavioral: Exercise

Flexibility

ACTIVE COMPARATOR

A non-progressive flexibility regimen using a stretch band. Participants will perform 2 sets of the following exercises: seated pelvic tilt, seated calf stretch, supine hamstring stretch, and supine gluteal stretch. Participants will exercise 3 times per week and an intensity of "very light" (9 on the Borg scale). All exercises will be performed during hemodialysis.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Each exercise will be performed during the first 2.5 hours of the participant's hemodialysis session. Exercises are semi supervised: the kinesiologist will supervise the initial three exercise sessions, any session that requires a change to the exercise prescription and on a minimum of a weekly basis.

Also known as: Monark ergometers, TherapyTrainer ergometers, TheraBand Stretch Strap, The Cuff ankle weights

Aerobic exercise; Combined aerobic and resistance; Flexibility; Resistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult (age ≥18)
• dialysis dependent for ≥ 3 consecutive months
• receiving ≥ 3 dialysis treatments per week
• mobile (any distance and can be with the assistance of an aid)
• at least one non-prosthetic and functional limb
• stable during hemodialysis treatment (assessed by hemodialysis unit staff and the study physician)
• capable of providing consent

You may not qualify if:

• currently enrolled in a clinical trial
• missing an average of more than 2 shifts per month
• planned move or modality change within the next 4 months
• currently enrolled in a structured exercise program
• scheduled hospitalization for \> 1 week
• any uncontrolled medical condition that would preclude participation in a low/moderate intensity exercise program (e.g. unstable angina, uncontrolled hypertension, severe valvular heart disease)

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Innovates Health Solutions: collaborator

Study Sites (1)

University of Alberta Hospital, outpatient dialysis unit

Edmonton, Alberta, T6G 2P4, Canada

Location

Related Publications (2)

• Thompson S, Klarenbach S, Molzahn A, Lloyd A, Gabrys I, Haykowsky M, Tonelli M. Randomised factorial mixed method pilot study of aerobic and resistance exercise in haemodialysis patients: DIALY-SIZE! BMJ Open. 2016 Sep 6;6(9):e012085. doi: 10.1136/bmjopen-2016-012085.

  PMID: 27601500 RESULT

• Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.

  PMID: 35018639 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stephanie Thompson, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Scott Klarenbach, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Marcello Tonelli, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 9, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 19, 2022

Record last verified: 2015-04

Locations

CA (1)