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RecruitingNCT06223802Updated Jan 25, 2024

Biodex Training in Hemodialysis Females With Osteopenia

An interventional study of biodex training in Hemolysis, sponsored by Ahram Canadian University. Recruiting at 1 site in Egypt. Open to female participants aged 35 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-01-25.

Sponsored by Ahram Canadian University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
35 Years to 45 Years
Sex
Female
01

Study summary

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

Read the 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)

02

Conditions studied

03

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • osteopneia women
  • hemodialysis women

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • autoimmune disorders
  • lower limb orthopedic problems
  • psychological manifestaion
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
58 participants (estimated)

Study arms

  • 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

  • No intervention
    non trained group

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

Interventions

  • Behavioralbiodex 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

05

What researchers measure

Primary outcomes

  1. bone mineral density of femur bone

    it will be measured by DEXA

    Time frame: it will be measured after 12 weeks

Secondary outcomes

  1. overall stability index

    it a parameter indicates the good balance of patients

    Time frame: it will be measured after 12 weeks

  2. Antero posterior stability index

    it a parameter indicates the good balance of patients

    Time frame: it will be measured after 12 weeks

  3. Mediolateral stability index

    it a parameter indicates the good balance of patients

    Time frame: it will be measured after 12 weeks

  4. six minute walk test

    it a parameter asses funntional capacity

    Time frame: it will be measured after 12 weeks

  5. Short physical performance battery

    total score or points will be assessed from this physical performance test

    Time frame: it will be measured after 12 weeks

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT06223802
Lead sponsor
Ahram Canadian University
Responsible party
Hagar Ahmed El-Hadidy (lecturer of physical therapy for Internal Medicine and Geriatrics, Ahram Canadian University) — Principal investigator
First posted
Jan 25, 2024
Start date
Nov 8, 2023
Primary completion
Mar 8, 2024 (estimated)
Completion
Mar 8, 2024 (estimated)
Last update
Jan 25, 2024

Study contacts

hagar El-Hadidy, lecturer
Contact
hagarhadidy2016@gmail.com
01007453552
omnia mahmoud
Contact
omniasaeedmahmoud2021@gmail.com
01227805225
hagar El-Hadidy, lecturer
principal investigator · Ahram Canadian University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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