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OpenTrials
Completed

NCT Number: NCT04898218

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

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).

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ziauddin University

Karachi, 74700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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.

Primary outcomes

  1. Gait Velocity

    Time frame: Baseline

    Temporal Spatial Gait Parameter

  2. Gait Velocity

    Time frame: 12 weeks

    Temporal Spatial Gait Parameter

  3. Cadence

    Time frame: Baseline

    Temporal Spatial Gait Parameter

  4. Cadence

    Time frame: 12 weeks

    Temporal Spatial Gait Parameter

  5. Gait Stability Ratio

    Time frame: Baseline

    Temporal Spatial Gait Parameter

  6. Gait Stability Ratio

    Time frame: 12 weeks

    Temporal Spatial Gait Parameter

  7. Balance

    Time frame: Baseline

    Balance was measured through Timed-up and Go Test

  8. Balance

    Time frame: 12 weeks

    Balance was measured through Timed-up and Go Test

  9. Fear of Fall

    Time frame: Baseline

    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.

  10. Fear of Fall

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Bone Mineral Density

    Time frame: Baseline

    Measured through Peripheral DXA Scan on right side calcaneal bone

  2. Bone Mineral Density

    Time frame: 12 weeks

    Measured through Peripheral DXA Scan on right side calcaneal bone

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 24, 2021
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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