Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females

Osteoporosis Clinical Trial

Official title:

Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04898218
• Other study ID #: Amna Khan
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: December 24, 2018

Study information

• Verified date: May 2021
• Source: Ziauddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the increase in life expectancy women spend more than one-third of their life time in post-menopausal state leading to osteoporosis in later stages. Therefore a decrease in temporal-spatial parameters of gait, high risk of fracture, imbalance in functional parameters, fear of fall and compromised health-related quality of life is observed among osteoporotic females. Several physical activities and balance training programs have been implemented globally but nationally no program has yet been designed catering gait balance and fear of fall altogether as a combined program. Therefore, the aim of this study was to determine the effectiveness of Osteoanabolic exercises on Temporal-Spatial gait parameters, Gait Stability Ratio (GSR) and Bone Mineral Density (BMD) among the osteoporotic females. Moreover, the effectiveness of these exercises was evaluated on dynamic balance using Timed Up and Go Test (TUG).

Furthermore, the impact on fear of fall was identified using Fall Efficacy ScaleInternational (FES-I).

Description:

A 3-arm Randomized Controlled Trial was conducted at the Department of Rehabilitation Sciences, Ziauddin Hospital using the envelope method. The participants were screened on the Physical Activity Readiness and You Questionnaire (PARQ &YOU). Ninety-three osteoporotic females were randomly allocated into three groups; where; participant in group A' received aerobic training protocol, a participant in group B' resistance training and participant in group C' Osteoanabolic training. A Frequency Intensity Time Type (FITT) protocol according to the American College of Sports Medicine for aerobic and resistance training was incorporated whereas for Osteoanabolic group combination training protocol was used. Twelve weeks of training was conducted where pre and post readings were calculated using activPAL, TUG, FES-I and Peripheral DXA Scan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 24, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Postmenopausal osteoporotic females aged in between 50-75 years

• Not participating in any exercise program for the past 3 months

• Independently ambulatory were included in the study

Exclusion Criteria:

• Red flags that limit the recruitment of participants in an exercise program, for example, vertebral fracture, an unstable heart condition, malignancy

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Exercise
The exercises were performed for 12 weeks, for the maximum of 6 days/week for Osteoanabolic group, 5 days/week for aerobic group and 3 days/ week for a resistance group as per ACSM, FITT protocol.

Locations

Country	Name	City	State
Pakistan	Ziauddin University	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Velocity	Temporal Spatial Gait Parameter	Baseline
Primary	Gait Velocity	Temporal Spatial Gait Parameter	12 weeks
Primary	Cadence	Temporal Spatial Gait Parameter	Baseline
Primary	Cadence	Temporal Spatial Gait Parameter	12 weeks
Primary	Gait Stability Ratio	Temporal Spatial Gait Parameter	Baseline
Primary	Gait Stability Ratio	Temporal Spatial Gait Parameter	12 weeks
Primary	Balance	Balance was measured through Timed-up and Go Test	Baseline
Primary	Balance	Balance was measured through Timed-up and Go Test	12 weeks
Primary	Fear of Fall	Measured through Fall Efficacy Scale- International consisting of 16 items that are summed to calculate a total score from minimum 16 to maximum 64. Higher the score, greater the fear of falling.	Baseline
Primary	Fear of Fall	Measured through Fall Efficacy Scale- International consisting of 16 items that are summed to calculate a total score from minimum 16 to maximum 64. Higher the score, greater the fear of falling.	12 weeks
Secondary	Bone Mineral Density	Measured through Peripheral DXA Scan on right side calcaneal bone	Baseline
Secondary	Bone Mineral Density	Measured through Peripheral DXA Scan on right side calcaneal bone	12 weeks