Optimal Timing for Resistance Exercise in Hemodialysis
What Is the Optimal Timing for Intradialytic Resistance Exercise? A Randomized Controlled Trial
1 other identifier
interventional
41
1 country
2
Brief Summary
The study consists of two groups doing resistance exercise for the first and last two hours of the HD session. The investigators are planning to form the sample size of exercise training from 40 participants, which the investigators determined according to the power analysis the investigators have done based on the blood pressure outcome criterion. Participants who meet the inclusion criteria the investigators have set will be divided into two groups. A resistance exercise training will be given three days a week for eight weeks, with a total of 24 sessions. The number of IRCAs occurring in both groups and blood pressure values to be measured at the beginning and end of the HD session will be checked, and both parameters will be compared between the groups before and after the treatment after 8 weeks of training. Thus, the investigators aim to show how the time factor has an effect on blood pressure. In addition, muscle strength, physical performance and quality of life of participants before and after resistance exercise will be evaluated and compared between groups. The participants' blood pressure will be evaluated with a conventional cuffed sphygmomanometer, muscle strength, digital hand dynamometer, physical performance, Short Physical Performance Battery and Timed Up and Go Test, and their quality of life will be evaluated with the Kidney Disease Quality of Life-36 (KDQOL-36) quality of life questionnaire. In exercise training, sandbags will be used as resistance. In our study, which the investigators planned as a randomized controlled trial, stratified randomization method will be used to distribute the gender factor homogeneously in both groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2023
CompletedFirst Submitted
Initial submission to the registry
May 16, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedSeptember 29, 2025
September 1, 2025
5 months
May 16, 2023
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
systolic and diastolic blood pressure will be measured
Change from baseline and 8 weeks systolic and diastolic blood pressure
Secondary Outcomes (2)
The Short Physical Performance Battery Scale
baseline and 8 weeks
Kidney Disease Quality of Life-36
baseline and 8 weeks
Study Arms (2)
first two hours of exercise group
ACTIVE COMPARATORThis is the group that will do resistance exercise in the first two hours of the hemodialysis session.
last two hours of exercise group
ACTIVE COMPARATORThis is the group that will do resistance exercise in the last two hours of the hemodialysis session.
Interventions
The exercises were planned to be performed in 3 sets, 10 repetitions in each set, with 3 minutes rest between sets. Before starting the main exercises, it was planned to do 1 set of the same exercises without weight as a warm-up and cool-down exercise. Exercises were planned as lower extremity hip abduction, adduction, flexion and extension, straight leg raise, terminal knee extension, ankle flexion and bridge exercises. During the exercises, it was planned to be combined with breathing, paying attention to respiratory control.
Eligibility Criteria
You may qualify if:
- Have been on HD treatment for at least 6 months
- To be receiving HD treatment for 4 hours 3 days a week
- to 90 years old
You may not qualify if:
- Having angina pectoris or uncontrolled arrhythmia and uncontrolled hypertension
- Having communication or cognitive problems at a level that cannot fulfill the requirements of the tests
- Having an orthopedic problem that cannot do the exercise
- Have upcoming travel or kidney transplant plans
- Having an intradialytic hypotensive attack in 3 consecutive sessions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mus Alparslan University
Muş, Güzeltepe District, 49100, Turkey (Türkiye)
Marmara University
Istanbul, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
May 16, 2023
First Posted
June 5, 2023
Study Start
May 13, 2023
Primary Completion
October 7, 2023
Study Completion
December 30, 2023
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share