NCT06862336

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 2, 2025

Last Update Submit

March 2, 2025

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Kidney disease quality of life F

    pre intervention and re assessed after 2 months of treatment

  • chest expansion

    pre intervention and re assessed after 2 months of treatment

  • Six-minute walk test

    pre intervention and re assessed after 2 months of treatment

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

PLACEBO COMPARATOR

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

Interventions

intra-dialytic exercise program associated with medical treatmentPROCEDURE

* 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: -

Group A
inter-dialytic combined exercise program with their medicationsPROCEDURE

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.

Group B

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fifty patients with CKD, are on hemodialysis for longer than threemonths 3 sessions/ week.
  • Theirageswillrangefrom40 to 55yearsold.
  • Their body mass index is more than 18.5 and less than 29.9 %.
  • All patients have hemodynamic stability over the month before beginning the program.

You may not qualify if:

  • \. 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).
  • \. 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.
  • \. Patient with uncontrolled- diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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 of physical therapy

Study Record Dates

First Submitted

March 2, 2025

First Posted

March 6, 2025

Study Start

January 20, 2025

Primary Completion

March 20, 2025

Study Completion

April 1, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations

EG(1)