Interdialytic Resistance Exercises in with Chronic Kidney Diseases

Intradialytic Versus Interdialytic Resistance Exercises on Quality of Life in Patients with Chronic Kidney Diseases

Fifty chronic kidney disease patients' ages will range from 40 to 55 years. They will be selected from the dialysis unit. received intra-dialytic combined exercise program for 8 weeks(3 sessions/week), with their medical treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Procedure: intra-dialytic exercise program associated with medical treatment; Procedure: inter-dialytic combined exercise program with their medications

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Fifty patients with CKD, are on hemodialysis for longer than threemonths 3 sessions/ week.
2. Theirageswillrangefrom40 to 55yearsold.
3. Their body mass index is more than 18.5 and less than 29.9 %.

3-All patients have hemodynamic stability over the month before beginning the program.

Exclusion Criteria:

• 1. Severe Chest diseases(either obstructive or restrictive). 2. Clinical signs of a severe cardiac event.(eg, severe atherosclerosis, congestive heart failure), 3. Severepsychiatricorcognitiveimpairment,whounabletofollowcomment. 4. Neurological disorders affecting respiratory muscles or any muscular dystrophies(cervical disc or bulge).

  5. Patients with severe self-limiting illness (e.g., cancer). 6. peripheral artery disease in lower extremities. 7. Systolic blood pressure < 180 mmHg, diastolic blood pressure more than 105 mmHg, or heart rate above 120 bpm during dialysis.

  8. Patient with uncontrolled- diabetes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; twenty-five patients with CKD will receive intra-dialytic combined exercise program for8 weeks(3 sessions/week), with their medical treatment.	Procedure: intra-dialytic exercise program associated with medical treatment; Stretch for pectorals and calf muscles: Two sets - 3 times/ set.; Breathing exercises associated with upper limb movement.; Resistive exercise for hip abductors, hip flexors, and calf muscles by using theraband.; Sit to stand strengthening exercises: -
Placebo Comparator: Group B; twenty-five patients with CKD will receive the inter-dialytic combined exercise program with their medications.	Procedure: inter-dialytic combined exercise program with their medications; receive the inter-dialytic combined exercise program with their medications. Like the study group except for diaphragmatic breathing instead of breathing with upper limb exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring quadriceps and cuff muscles power	From sitting or lying positions the normal dialytic positions by handheld dynamometer	pre intervention and re assessed after 2 months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney disease quality of life F	Kidney disease quality of life questionnaire KDQoL-SF	pre intervention and re assessed after 2 months of treatment
chest expansion	From a standing position and comfortable clothes with relaxed shoulders and a straight back, the head will be aligned vertically. Putting the measuring tape around the armpits and closing the ends of the tape measurement not tightly nor loose, asking the patient to take deep breathing.	pre intervention and re assessed after 2 months of treatment
Six-minute walk test	Subjects will be instructed to walk from one end to the other of a 30-m hallway at their own pace while attempting to cover as much ground as possible in the allotted 6 min	pre intervention and re assessed after 2 months of treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): March 20, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 012/005019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No