NCT06445647

Brief Summary

Finding the effect of core stability exercises with breathing exercises on Activities of daily living (ADLs), fatigue level and balance in maintenance hemodialysis patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

June 30, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

May 2, 2025

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

May 30, 2024

Last Update Submit

May 1, 2025

Conditions

Keywords

Core ExerciseADLBalanceHemodialysis

Outcome Measures

Primary Outcomes (3)

  • Activities of Daily Livings (ADLs)

    ADLs will be assessed by Barthel Index (BI)

    up to 8 weeks

  • Fatigue

    Fatigue will be assessed by fatigue assessment scale. The total score ranges from 10 to 50. A total score \< 22 indicates no fatigue, a score ≥ 22 indicates fatigue.

    up to 8 weeks

  • Balance

    Balance will be assessed by berg balance scale, the balance score ranges from 0 to 56, with lower scores indicating increased risk of balance loss and higher scores indicating improved functional mobility. Time up and go test (TUG)n Score \< 10 seconds = normal \< 20 seconds = good mobility; can walk outside alone; does not require a walking aid \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.

    up to 8 weeks

Study Arms (2)

Study Group

ACTIVE COMPARATOR

30 hemodialysis patient

Other: core Stability exerciseOther: Breathing exercises

Control group

ACTIVE COMPARATOR

30 hemodialysis patient

Other: Breathing exercises

Interventions

core stability exercise training

Study Group

Deep breathing and diaphragmatic breathing exercises

Control groupStudy Group

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ranging from 55- 70 years old of both genders.
  • Diagnosed as maintenance hemodialysis for at least 6 months or more.
  • Free from mental illness, neuromuscular disorders, and serious lung problems and able to implement the interventional exercise.

You may not qualify if:

  • Obesity (BMI ≥ 30 kg/m2)
  • Orthopeadics or neurological problems that interferes with training.
  • History of pulmonary problems (COPD, pneumonia)
  • History of Myocardial infarction and/or cardiothoracic surgery
  • Unstable medical status
  • Dementia that interferes with the ability to follow instructions.
  • History Chronic Fatigue Syndrome (CFS).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kz hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Mohammed S Saif

    National institute for Gerontology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Yo Elhamrawy, Ph.D

CONTACT

Mohammed S Saif, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical therapy

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 6, 2024

Study Start

June 30, 2024

Primary Completion

August 15, 2025

Study Completion

November 15, 2025

Last Updated

May 2, 2025

Record last verified: 2024-07

Locations