HemodialysisNCT07865754
Determination of Optimal Exercise Duration Using Intradialytic Exercises on Dialysis Adequacy, Fatigue, Depression, VO2 Max, Muscle Strength, Physical Functioning, and Quality of Life in Patients Undergoing Hemodialysis
A study testing Combined Aerobic and Resistance Exercise in people with Hemodialysis, run by Ibadat International University, Islamabad.
Trial summary
The purpose of this randomized controlled trial is to determine the optimal exercise duration of a combined exercise program (aerobic + resistance) in patients undergoing hemodialysis by evaluating its effects on dialysis adequacy, fatigue, depression, VO2 max, muscle strength, physical functioning, and QOL in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Combined Aerobic and Resistance Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged above 18 years and willing to participate.
- Diagnosed with ESRD, undergoing hemodialysis for at least three months, receiving hemodialysis three times per week.
- Stable medical condition as determined by the treating nephrologist.
- Able to participate in exercise sessions without contraindications.
Who cannot join
- Unstable medical condition, such as recent cardiovascular events or respiratory failure.
- Carcinoma
- Pregnancy
- Kidney transplant candidate
- Hearing or visual impairments
- Severe musculoskeletal impairments limiting exercise participation.
- Cognitive impairment hindering comprehension and compliance.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this randomized controlled trial is to determine the optimal exercise duration of a combined exercise program (aerobic + resistance) in patients undergoing hemodialysis by evaluating its effects on dialysis adequacy, fatigue, depression, VO2 max, muscle strength, physical functioning, and QOL in patients undergoing hemodialysis.
- Conditions
- Hemodialysis
- Being tested
- Combined Aerobic and Resistance Exercise
- Keywords
- Dialysis Adequacy, Fatigue, Hemodialysis, Intradialytic Exercises, Quality of life
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Aerobic and Resistance ExerciseOther
Arm 1: Group A - 30-Minute Exercise Intervention Participants will receive a 30-minute combined aerobic and resistance exercise program. Each session will include 5 minutes of warm-up (active ROM and deep breathing), 10 minutes of moderate-intensity stationary cycling (RPE 11-13), 10 minutes of resistance exercise at approximately 60% 1-RM, and 5 minutes of cool-down. Resistance exercises will include upper- and lower-limb exercises using weight cuffs. Participants will perform 1 set of 10 repetitions per exercise, with 10-15 seconds of rest between exercises. Resistance will be progressed weekly according to 1-RM.
Combined Aerobic and Resistance ExerciseOther
Arm 2: Group B - 40-Minute Exercise Intervention Participants will receive a 40-minute combined aerobic and resistance exercise program. Each session will include 5 minutes of warm-up, 15 minutes of moderate-intensity stationary cycling (RPE 11-13), 15 minutes of resistance exercise at approximately 60% 1-RM, and 5 minutes of cool-down. Participants will perform 1 set of 15 repetitions per resistance exercise, with 10-15 seconds of rest between exercises. Resistance will be progressed weekly according to 1-RM.
Combined Aerobic and Resistance ExerciseOther
Arm 3: Group C - 50-Minute Exercise Intervention Participants will receive a 50-minute combined aerobic and resistance exercise program. Each session will include 5 minutes of warm-up, 20 minutes of moderate-intensity stationary cycling (RPE 11-13), 20 minutes of resistance exercise at approximately 60% 1-RM, and 5 minutes of cool-down. Participants will perform 2 sets of 10 repetitions per resistance exercise, with 10-15 seconds of rest between exercises. Resistance will be progressed weekly according to 1-RM.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 30-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 30-minute combined aerobic and resistance exercise program Receives: Other: Combined Aerobic and Resistance Exercise |
| Group B | Experimental | 40-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 40-minute combined aerobic and resistance exercise program. Receives: Other: Combined Aerobic and Resistance Exercise |
| Group C | Experimental | Group C - 50-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 50-minute combined aerobic and resistance exercise program. Receives: Other: Combined Aerobic and Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis adequacy
Dialysis adequacy will be assessed using the Kt/V value obtained through direct measurement from the dialyzer. Kt/V is a measure of urea clearance during hemodialysis and will be used to evaluate the adequacy of dialysis treatment.
Measured: Baseline, Week 6, and Week 12.
Muscle Strength
Muscle strength will be assessed using an electronic hand dynamometer. Grip strength will be measured according to a standardized testing procedure.
Measured: Baseline, Week 6, and Week 12
Physical Functioning
Physical functioning will be assessed using the 6-Minute Walk Test. Participants will be instructed to walk for 6 minutes at their own maximal sustainable pace, and the total distance walked in meters will be recorded. Greater walking distance will indicate better functional exercise capacity.
Measured: Baseline, Week 6, and Week 12
Secondary outcomes (4)
VO₂ Max
VO₂ max will be assessed using the 6-minute walk test. Participants will walk for 6 minutes on a 30-meter flat surface, and the total distance covered in six minutes will be recorded in meters. Heart rate and systolic blood pressure will be measured before and immediately after the test. Estimated peak oxygen uptake will be calculated using the validated Cahalin prediction equation.
Measured: Baseline, Week 6, and Week 12
Fatigue
Fatigue will be assessed objectively during the 6-Minute Walk Test (6MWT) by comparing the distance walked during the first and sixth minutes. The Walking Distance Index (DWI) will be calculated as DWI = [(distance walked during the sixth minute - distance walked during the first minute) / distance walked during the first minute] × 100. More negative DWI values indicate greater decline in walking performance during the test and therefore greater walking-related performance fatigability.
Measured: Baseline, Week 6, and Week 12
Depression
Depressive symptoms will be assessed using the validated Urdu version of the Depression Anxiety Stress Scale-21 (DASS-21 Urdu). The depression subscale will be used to quantify the severity of depressive symptoms, with higher scores indicating greater symptom severity.
Measured: Baseline, Week 6, and Week 12.
Health-related quality of life
Quality of life will be assessed using the Kidney Disease Quality of Life-36 questionnaire. The instrument assesses kidney disease-specific quality of life and the impact of kidney disease and its treatment on participants' physical and mental well-being. Scores will be calculated according to the instrument's scoring procedure, with higher scores indicating better health-related quality of life.
Measured: Baseline, Week 6, and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somiya Naz, Ibadat International University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865754
- Sponsor's protocol ID
- IIUI/RERC/ADT/2026/07/424
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Optimal Exercise Duration Using Intradialytic Exercises on Dialysis Adequacy, Fatigue, Depression, VO2 Max, Muscle Strength, Physical Functioning, and Quality of Life in Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT07865754
- Acronym / sponsor ID
- IIUI/RERC/ADT/2026/07/424
- Conditions
- Hemodialysis
- Keywords
- Dialysis Adequacy, Fatigue, Hemodialysis, Intradialytic Exercises, Quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized controlled trial is to determine the optimal exercise duration of a combined exercise program (aerobic + resistance) in patients undergoing hemodialysis by evaluating its effects on dialysis adequacy, fatigue, depression, VO2 max, muscle strength, physical functioning, and QOL in patients undergoing hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Combined Aerobic and Resistance Exercise30-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 30-minute combined aerobic and resistance exercise program |
| Group B | Experimental | Other: Combined Aerobic and Resistance Exercise40-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 40-minute combined aerobic and resistance exercise program. |
| Group C | Experimental | Other: Combined Aerobic and Resistance ExerciseGroup C - 50-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 50-minute combined aerobic and resistance exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients aged above 18 years and willing to participate.
- Diagnosed with ESRD, undergoing hemodialysis for at least three months, receiving hemodialysis three times per week.
- Stable medical condition as determined by the treating nephrologist.
- Able to participate in exercise sessions without contraindications.
Key exclusion criteria (7 listed)
- Unstable medical condition, such as recent cardiovascular events or respiratory failure.
- Carcinoma
- Pregnancy
- Kidney transplant candidate
- Hearing or visual impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Aerobic and Resistance ExerciseArm 1: Group A - 30-Minute Exercise Intervention Participants will receive a 30-minute combined aerobic and resistance exercise program. Each session will include 5 minutes of warm-up (active ROM and deep breathing), 10 minutes of moderate-intensity stationary cycling (RPE 11-13), 10 minutes of resistance exercise at approximately 60% 1-RM, and 5 minutes of cool-down. Resistance exercises will include upper- and lower-limb exercises using weight cuffs. Participants will perform 1 set of 10 repetitions per exercise, with 10-15 seconds of rest between exercises. Resistance will be progressed weekly according to 1-RM. | Other | Group A |
| Combined Aerobic and Resistance ExerciseArm 2: Group B - 40-Minute Exercise Intervention Participants will receive a 40-minute combined aerobic and resistance exercise program. Each session will include 5 minutes of warm-up, 15 minutes of moderate-intensity stationary cycling (RPE 11-13), 15 minutes of resistance exercise at approximately 60% 1-RM, and 5 minutes of cool-down. Participants will perform 1 set of 15 repetitions per resistance exercise, with 10-15 seconds of rest between exercises. Resistance will be progressed weekly according to 1-RM. | Other | Group B |
| Combined Aerobic and Resistance ExerciseArm 3: Group C - 50-Minute Exercise Intervention Participants will receive a 50-minute combined aerobic and resistance exercise program. Each session will include 5 minutes of warm-up, 20 minutes of moderate-intensity stationary cycling (RPE 11-13), 20 minutes of resistance exercise at approximately 60% 1-RM, and 5 minutes of cool-down. Participants will perform 2 sets of 10 repetitions per resistance exercise, with 10-15 seconds of rest between exercises. Resistance will be progressed weekly according to 1-RM. | Other | Group C |
Primary outcome
Dialysis adequacy
Time frame: Baseline, Week 6, and Week 12.
Dialysis adequacy will be assessed using the Kt/V value obtained through direct measurement from the dialyzer. Kt/V is a measure of urea clearance during hemodialysis and will be used to evaluate the adequacy of dialysis treatment.
Muscle Strength
Time frame: Baseline, Week 6, and Week 12
Muscle strength will be assessed using an electronic hand dynamometer. Grip strength will be measured according to a standardized testing procedure.
Physical Functioning
Time frame: Baseline, Week 6, and Week 12
Physical functioning will be assessed using the 6-Minute Walk Test. Participants will be instructed to walk for 6 minutes at their own maximal sustainable pace, and the total distance walked in meters will be recorded. Greater walking distance will indicate better functional exercise capacity.
4 secondary outcomes
VO₂ Max
Time frame: Baseline, Week 6, and Week 12
Fatigue
Time frame: Baseline, Week 6, and Week 12
Depression
Time frame: Baseline, Week 6, and Week 12.
Health-related quality of life
Time frame: Baseline, Week 6, and Week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Aerobic and Resistance Exercise in people with Hemodialysis, run by Ibadat International University, Islamabad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Somiya Naz, BSPT, PPDPT, PHD Scholar (923315163093, somiyanaz@uipt.iiui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis adequacy (time frame: Baseline, Week 6, and Week 12.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.