NCT06223802

Brief Summary

imbalance is a common problem in hemodialysis patients with osteopneia, biodex training is a good device that treat imbalance

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 8, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 16, 2024

Last Update Submit

January 16, 2024

Conditions

Hemolysis

Outcome Measures

Primary Outcomes (1)

  • bone mineral density of femur bone

    it will be measured by DEXA

    it will be measured after 12 weeks

Secondary Outcomes (5)

  • overall stability index

    it will be measured after 12 weeks

  • Antero posterior stability index

    it will be measured after 12 weeks

  • Mediolateral stability index

    it will be measured after 12 weeks

  • six minute walk test

    it will be measured after 12 weeks

  • Short physical performance battery

    it will be measured after 12 weeks

Study Arms (2)

trained group

EXPERIMENTAL

women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks

Behavioral: biodex training

non trained group

NO INTERVENTION

this group will serve as a control group that will receive no intervention

Interventions

biodex trainingBEHAVIORAL

women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks

trained group

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • osteopneia women
  • hemodialysis women

You may not qualify if:

  • pregnancy
  • autoimmune disorders
  • lower limb orthopedic problems
  • psychological manifestaion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahram canadian university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • hagar El-Hadidy, lecturer

    Ahram Canadian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hagar El-Hadidy, lecturer

CONTACT

01007453552hagarhadidy2016@gmail.com

omnia mahmoud

CONTACT

01227805225omniasaeedmahmoud2021@gmail.com

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 for Internal Medicine and Geriatrics

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 25, 2024

Study Start

November 8, 2023

Primary Completion

March 8, 2024

Study Completion

March 8, 2024

Last Updated

January 25, 2024

Record last verified: 2024-01

Locations

EG(1)