Biodex Training in Hemodialysis Females With Osteopenia

January 16, 2024 updated by: Hagar Ahmed El-Hadidy, Ahram Canadian University

Balance Response to Biodex Training in Hemodialysis Females With Osteopenia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

58 women with osteopenia problem and dialysis will be divided to trained women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks or nontrained women group that will act as a control group (n = 29 women)

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • osteopneia women
  • hemodialysis women

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: trained group
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
women group with a number of 29 women receiving 3-time biodex training per week, every time will be 10 minutes for 12 weeks
No Intervention: non trained group
this group will serve as a control group that will receive no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone mineral density of femur bone
Time Frame: it will be measured after 12 weeks
it will be measured by DEXA
it will be measured after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall stability index
Time Frame: it will be measured after 12 weeks
it a parameter indicates the good balance of patients
it will be measured after 12 weeks
Antero posterior stability index
Time Frame: it will be measured after 12 weeks
it a parameter indicates the good balance of patients
it will be measured after 12 weeks
Mediolateral stability index
Time Frame: it will be measured after 12 weeks
it a parameter indicates the good balance of patients
it will be measured after 12 weeks
six minute walk test
Time Frame: it will be measured after 12 weeks
it a parameter asses funntional capacity
it will be measured after 12 weeks
Short physical performance battery
Time Frame: it will be measured after 12 weeks
total score or points will be assessed from this physical performance test
it will be measured after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahram Canadian University

Investigators

  • Principal Investigator: hagar El-Hadidy, lecturer, Ahram Canadian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2023

Primary Completion (Estimated)

March 8, 2024

Study Completion (Estimated)

March 8, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004928

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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