Clinical trial NCT04898218: Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females
Official title: Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Osteoporosis
Bone Mineral Density
Postmenopausal
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 93
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait Velocity
timeFrame: Baseline
measure: Gait Velocity
timeFrame: 12 weeks
measure: Cadence
timeFrame: Baseline
measure: Cadence
timeFrame: 12 weeks
measure: Gait Stability Ratio
timeFrame: Baseline
measure: Gait Stability Ratio
timeFrame: 12 weeks
measure: Balance
timeFrame: Baseline
measure: Balance
timeFrame: 12 weeks
measure: Fear of Fall
timeFrame: Baseline
measure: Fear of Fall
timeFrame: 12 weeks
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: Baseline
measure: Bone Mineral Density
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ziauddin University
Study officials:
affiliation: Ziauddin University
name: Amna Khan
role: PRINCIPAL_INVESTIGATOR
References: