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临床试验/NCT04898218
NCT04898218已完成不适用

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

Ziauddin University1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2017年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
1
主要终点
Cadence

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Group B (Resistance Exercise Group)

Active Comparator

Group B was instructed for strengthening exercises of ten major muscle groups that include Biceps, Triceps, Pectoralis Major, Deltoid, Latissimus Dorsi, Abdominals, Back Extensors, Hamstrings, Quadriceps and Calf. The intensity of the weight-bearing exercises was calculated using 1 Repetition Maximum (RM) method.

干预措施: Exercise (Other)

Group C (Osteoanabolic Exercise Group)

Experimental

Group C was performed Osteoanabolic exercise divided into two different phases:

Aerobic Conditioning Phase Participants were instructed to walk on treadmill for 30-60 min. The intensity of the exercises was 55-75% MHR, calculated by Karvonen method. Intensity gradually raised up to the Targeted Heart Rate (THR). Once the THR is achieved the intensity was gradually decelerated and patient proceeded for the cool-down phase. The participants performed 3 days per week for 12 weeks on alternative days.

Anaerobic (Resistance) Conditioning Phase Resistance training was started on every alternative day of the aerobic conditioning (3 days per week) for 45 min. The intensity of the weight-bearing exercises was calculated using 1 RM method. Resistance training muscle and protocol was the same as for Group B. The participants performed warm-up and cool down similar to that of group A and group B.

干预措施: Exercise (Other)

Group A (Aerobic Exercise Group)

Active Comparator

Warm-up exercises were performed by the participants on a cycle ergometer for a duration of 5-10 minutes. Group A was advised to start walking at a comfortable speed on a treadmill for the duration of 30-60 minutes; the intensity of the exercises was 55-75% of MHR, calculated by using a Karvonen method. Initially with the minimum intensity that was gradually raised up to the intensity of Targeted Heart Rate (THR). Once the THR is achieved the intensity was gradually decelerated and patient proceeded for the cool-down phase for 5-10 min.

干预措施: Exercise (Other)

结局指标

主要结局

Cadence

时间窗: 12 weeks

Temporal Spatial Gait Parameter

Gait Velocity

时间窗: 12 weeks

Temporal Spatial Gait Parameter

Gait Stability Ratio

时间窗: 12 weeks

Temporal Spatial Gait Parameter

Balance

时间窗: 12 weeks

Balance was measured through Timed-up and Go Test

Fear of Fall

时间窗: 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.

Gait Velocity

时间窗: Baseline

Temporal Spatial Gait Parameter

Cadence

时间窗: Baseline

Temporal Spatial Gait Parameter

Gait Stability Ratio

时间窗: Baseline

Temporal Spatial Gait Parameter

Balance

时间窗: Baseline

Balance was measured through Timed-up and Go Test

Fear of Fall

时间窗: 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.

次要结局

  • Bone Mineral Density(12 weeks)
  • Bone Mineral Density(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Amna Khan

Principal Investigator, Assistant Professor

Ziauddin University

研究点 (1)

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