Comparing Effect of Intradialytic Aerobic Exercise Versus Incentive Spirometer on Fatigue and Sleep Quality Among Hemodialysis Patients.

NCT07386691 | Active Not Recruiting

• 1 other identifier: BaghdadU Unique Protocol ID
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

In order to accomplish the objectives of this investigation, a single-blind experimental comparative design was implemented to evaluate the impact of intradialytic aerobic exercise and Incentive Spirometer on sleep quality and fatigue. Three experimental groups (aerobic exercise and Incentive Spirometer) and one control group were subjected to pre- and post-tests. Is there a difference in the levels of fatigue and sleep quality between hemodialysis patients who receive aerobic exercise and incentive spirometer therapy and those who do not receive it? Researcher will compare the levels of fatigue and sleep quality between hemodialysis patients who receive interventional therapy and those who do not receive it to see if interventional therapy works to relieve the fatigue and improve sleep quality. Participants will take aerobic exercise therapy group applied on the leg muscles for 20 minutes per session, and incentive spirometer group on respiratory muscles

• Ask the patient to hold the breath as long as possible (at least five seconds) then exhale slowly.
• Session was in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets , 2 times per week for total one month, during the first hour of each hemodialysis. sessions.

Conditions

Fatigue; Sleep Disturbance; Hemodialysis Complication

Keywords

fatigue; sleep quality; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Fatigue assessment

  Fatigue will be measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Higher scores indicate less fatigue.

  There will be three time points at which the measurement is assessed for both the study and the control group as follows: Pretest: At the first day Post-test 1:two weeks later . Post-test 2: four weeks later.

• Sleep quality

  Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 indicates poor sleep quality.

  There will be three time points at which the measurement is assessed for both the study and the control group as follows: Pretest: At the first day Post-test 1: two weeks later . Post-test 2: four weeks later.

Study Arms (3)

intradialytic aerobic exercise

EXPERIMENTAL

the best time for experimental is 30min after the initiation and during the first 2 h of dialysis . The researcher placed the bike on the bed, fixed the patient's feet to the pedals using adhesive straps, and knee range of motion was determined for each subject. Patients performed passive pedaling at low power for 20 min at a speed of 30rpm during the first 2h of every dialysis session. Participants were instructed on how to exercise and verbal encouragement was provided to them during exercise. Before, during, and after exercise, clinical assessment, blood pressure, heart rate and body temperature were obtained. If the participant had a blood pressure of 180/110 mmHg and higher, systolic pressure lower than 90mmHg, chest pain, shortness of breath, or high body temperature (\> 37.8oC) before or during dialysis, the exercise would be discontinued. None of the patients suffered from such complications and all participated with out interruption.

Other: intradialytic aerobic exercise versus incentive spirometer

Incentive Spirometer

EXPERIMENTAL

using incentive spirometer : - Loosen any tight clothing, especially around neck. * Each patient was instructed to sit upright with placing incentive spirometer at the same level of his mouth to promote optimal lung expansion while using the spirometer. * The patient was instructed to exhale letting all the breath out. * Ask the patient to close the lips around the mouthpiece of the spirometer. * Instruct the patient to inhale slowly, breathing in until unable to do any more, this would raise the balls to the top of the column. * Ask the patient to hold the breath as long as possible (at least five seconds) then exhale slowly. * Session was in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets. * Intensity of exercise was increased by increasing time of session, time of holding the breath and numbers of repetitions according to patient's status. * The training was 2 times/week for 4 weeks

Other: intradialytic aerobic exercise versus incentive spirometer

control group

NO INTERVENTION

Routine care control group will not exposed to the intervention therapy and will take only routine care

Interventions

intradialytic aerobic exercise versus incentive spirometer OTHER

The interventions were implemented during the first two hours of the hemodialysis session, starting 30 minutes after initiation. For intradialytic aerobic exercise, the cycle ergometer was placed on the bed, the patients' feet were secured to the pedals, and knee range of motion was assessed individually. pedaling was performed for 20 minutes at a speed of 30 rpm during each session, with instructions and verbal encouragement provided. Vital signs (blood pressure, heart rate, and body temperature) were monitored before, during, and after exercise. Regarding the use of the Incentive Spirometer, patients were seated upright and instructed to perform slow deep inhalation with breath holding for at least 5 seconds, followed by slow exhalation. Each session consisted of 30 repetitions divided into sets (5-6 repetitions per set) with a one-minute rest between sets. Exercise intensity was progressively increased according to the patient's condition. Training was conducted twice weekly

Incentive Spirometer; intradialytic aerobic exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 18-60 years
• Diagnosed with end-stage renal disease and receiving maintenance hemodialysis
• On hemodialysis for at least 3 months
• Experiencing fatigue and sleep disturbances
• Clinically stable during the study period
• Able to communicate and provide written informed consent

You may not qualify if:

• Unstable cardiovascular disease
• Severe musculoskeletal disorders limiting exercise
• Cognitive impairment
• Patients with diabetes mellitus for at least 10 years with diabetic neuropathy (DPN ≥ 6)
• Recent hospitalization within the last 4 weeks
• Refusal to participate or inability to continue participation

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad

Baghdad, Iraq

Location

MeSH Terms

Conditions

Fatigue; Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Haider A mohammed, PhD

  Al Qadisiyah University-Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist Lecturer

Model Details: This randomized controlled trial aims to compare the effects of intradialytic aerobic exercise versus incentive spirometer breathing exercises on fatigue and sleep quality among patients undergoing maintenance hemodialysis. Eligible participants will be randomly assigned to one of three parallel groups: intradialytic aerobic exercise, incentive spirometer intervention, or routine care (control group).

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 4, 2026
• Study Start: January 22, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

IR (1)