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Not yet recruitingNCT07865754Updated Oct 8, 2026

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

An interventional study of Combined Aerobic and Resistance Exercise and Combined Aerobic and Resistance Exercise in Hemodialysis, sponsored by Ibadat International University, Islamabad. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Ibadat International University, Islamabad · Not applicable, Interventional, and Treatment

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 patients undergoing hemodialysis.

02

Conditions studied

  • Hemodialysis

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Keywords

  • Dialysis Adequacy, Fatigue, Hemodialysis, Intradialytic Exercises, Quality of life
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's planned enrollment of 120 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Ibadat International University, Islamabad is the lead sponsor of 49 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Group A

    30-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 30-minute combined aerobic and resistance exercise program

    Other: Combined Aerobic and Resistance Exercise

  • Experimental
    Group B

    40-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 40-minute combined aerobic and resistance exercise program.

    Other: Combined Aerobic and Resistance Exercise

  • Experimental
    Group C

    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.

    Other: Combined Aerobic and Resistance Exercise

Interventions

  • OtherCombined Aerobic and Resistance Exercise

    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.

  • OtherCombined Aerobic and Resistance Exercise

    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.

  • OtherCombined Aerobic and Resistance Exercise

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 6, and Week 12.

  2. Muscle Strength

    Muscle strength will be assessed using an electronic hand dynamometer. Grip strength will be measured according to a standardized testing procedure.

    Time frame: Baseline, Week 6, and Week 12

  3. 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.

    Time frame: Baseline, Week 6, and Week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline, Week 6, and Week 12

  2. 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.

    Time frame: Baseline, Week 6, and Week 12

  3. 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.

    Time frame: Baseline, Week 6, and Week 12.

  4. 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.

    Time frame: Baseline, Week 6, and Week 12.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07865754
Lead sponsor
Ibadat International University, Islamabad
Responsible party
Somiya Naz (Assistant Professor, Ibadat International University, Islamabad) — Principal investigator
First posted
Oct 8, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Jan 15, 2027 (estimated)
Completion
Jan 20, 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Somiya Naz, BSPT, PPDPT, PHD Scholar
Contact
somiyanaz@uipt.iiui.edu.pk
923315163093

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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