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

NCT ID: NCT06264401

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-06-02

Brief Summary

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

Detailed 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.

Conditions

Postmenopausal Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placepo group

Alendronate:

the experimental and control group received (Alendronate) 70 mg 1 tab every week for 4 months.

Group Type: EXPERIMENTAL

Alendronate

Intervention Type: OTHER

control group received (Alendronate) 70 mg 1 tab every week.

exercises and alendronate group

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.

Group Type: EXPERIMENTAL

Alendronate

Intervention Type: OTHER

control group received (Alendronate) 70 mg 1 tab every week.

treatment exercises

Intervention Type: OTHER

the experimental group performed core stability and dynamic resistance exercises, a 45-min lumbar-pelvic/core strength and stability exercise program, 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 minutes.

Interventions

Alendronate

control group received (Alendronate) 70 mg 1 tab every week.

Intervention Type: OTHER

treatment exercises

the experimental group performed core stability and dynamic resistance exercises, a 45-min lumbar-pelvic/core strength and stability exercise program, 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 minutes.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nermeen Shaaban Abd El Azeim

principle investgator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Emara, phd

Role: STUDY_CHAIR

Cairo University

Locations

faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

Other Identifiers

menopausal with osteoporsis

Identifier Type: -

Identifier Source: org_study_id