NCT05889130

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

May 16, 2023

Last Update Submit

September 23, 2025

Conditions

Keywords

HemodialysisResistant exerciseBlood PresurePhysical PerformanceQuality of Life

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 COMPARATOR

This is the group that will do resistance exercise in the first two hours of the hemodialysis session.

Other: Resistant Exercise

last two hours of exercise group

ACTIVE COMPARATOR

This is the group that will do resistance exercise in the last two hours of the hemodialysis session.

Other: Resistant Exercise

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.

first two hours of exercise grouplast two hours of exercise group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

Marmara University

Istanbul, Turkey (Türkiye)

Location

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

Locations