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Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Postmenopausal Osteoporosis

Treatments

Other: Alendronate
Other: treatment exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT06264401
menopausal with osteoporsis

Details and patient eligibility

About

osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population.

Full description

Ethics statement This study was approved by the institutional review board of the faculty of physical therapy, Cairo university, Egypt (no.P.T. REC/012/003867) and strictly adhered to the criteria proclaimed in the latest version of the declaration of Helsinki code of ethics. each woman freely consents to participate in this research study.

study design. A prospective double-masked randomized controlled trial.

sample size calculation. Based on a pilot study, sample size was calculated according to the significant difference in the value of mean difference (pretreatments - posttreatment values) of ODI between control (16.60 ± 2.22) and study (26.50 ± 4.09) groups in two tailed unpaired t test, with α=0.05, power of 80%, and an effect size of 0.74. So, a sample size of 30 patients/per group would be required and increased to 35 women to allow for a 15% dropout rate (Power 301 http: www.psycho.uni-duesseldorf.de) Randomization. Randomization of sample selection were achieved using closed envelop way to allocate study participants to either intervention group (medication and treatment exercises) control group (medication only). all postmenopausal women and examiners were unaware of group allocation.

Enrollment

60 patients

Sex

Female

Ages

50 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Their ages were ranged from 50-60 years.
  • Their BMI not exceeded 30 kg/m2.
  • All postmenopausal women past of at least one year after menopause.
  • Had no regular physical activities during the past 6 months.

Exclusion criteria

  • Patients didn't take any drug before the study (e.g. calcium tablets, multivitamins containing calcium and vitamin D) that affects bone metabolism.
  • Patients that were smoking or having alcohol consumption.
  • Histories of fracture and surgery, or severe injuries

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

placepo group
Experimental group
Description:
Alendronate: the experimental and control group received (Alendronate) 70 mg 1 tab every week for 4 months.
Treatment:
Other: Alendronate
exercises and alendronate group
Experimental group
Description:
alendronate: the experimental and control group received (Alendronate) 70 mg 1 tab every week for 4 months. treatment exercises: the experimental group performed core stability and dynamic resistance exercises, a 45-min lumbar-pelvic/core strength and stability exercise program which include 5 min warming up and 5 min cooling down at the end of the session each exercise was executed for three sets of 15 seconds, which gradually upgraded to three sets of 45-second at the fourth month and 10 sec rest between each set and dynamic resistance exercise performed by each woman for 2 sets for 8-12 repetitions gradually along the study of 90 sec rest between each set for a duration of 60 min including 10 min warming up and 10 min cooling down in form of stretching.
Treatment:
Other: treatment exercises
Other: Alendronate

Trial contacts and locations

1

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Central trial contact

Nermeen Abd El Aziem, phd

Data sourced from clinicaltrials.gov

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