跳至主要内容
临床试验/NCT04143464
NCT04143464Unknown不适用

The Effectiveness of Kyphosis-specific Exercise on Reducing the Angle of Kyphosis Among Chinese Older Adults With Thoracic Hyperkyphosis - a Randomized Control Trial

The University of Hong Kong2 个研究点 分布在 2 个国家目标入组 160 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
The change of the angle of kyphosis in degrees

研究概览

简要总结

Thoracic hyperkyphosis, an exaggerated curvature between the first thoracic vertebra body (T1) and the 12th thoracic vertebra body (T12), has a high prevalence among older adults. The cross-sectional study conducted by the Principal Investigator found 72% of older adults in the Chinese community have thoracic hyperkyphosis.

Thoracic kyphosis has been found having negative effects on self-image, physical function, respiratory function, pain, balance, and gait performance. Treatment options of thoracic hyperkyphosis included surgery, peptides injection, menopausal hormone therapy, bracing, traditional Chinese medicine therapies, and exercise.

The previous studies reported that different types of exercise such as strength training, pilates, yoga, and corrective exercise were effective in reducing the thoracic hyperkyphosis. However, the previous studies either excluded older adults who have exercise habits or lack of information about participants' daily activity levels. Besides, all the group spine exercise interventions in previous studies were delivered by professional trainers or physical therapists in the form of face-to-face exercise classes.

The current RCT will be conducted to provide kyphosis-specific exercise in the form of short video and face to face exercise classes as the intervention to Chinese older adults with thoracic hyperkyphosis. The RCT can test the effects of such kyphosis-specific exercise intervention on the angle of kyphosis, physical performance, pain, and self-image among Chinese older adults with thoracic hyperkyphosis. The investigator hypotheses that older adults receive kyphosis-specific exercise intervention (video and exercise class) have reduced the angle of kyphosis. And older adults receive kyphosis-specific exercise intervention (video and exercise class) have decreased pain, better self-image, and improved overall physical performance.

详细描述

Thoracic hyperkyphosis, an exaggerated curvature between the first thoracic vertebra body (T1) and the 12th thoracic vertebra body (T12), has a high prevalence among older adults. The cross-sectional study conducted by the Principal Investigator found 72% of older adults in the Chinese community have thoracic hyperkyphosis.

Thoracic kyphosis has been found having negative effects on self-image, physical function, respiratory function, pain, balance, and gait performance. Treatment options of thoracic hyperkyphosis included surgery, peptides injection, menopausal hormone therapy, bracing, traditional Chinese medicine therapies, and exercise.

The previous studies reported that different types of exercise such as strength training, pilates, yoga, and corrective exercise were effective in reducing the thoracic hyperkyphosis. However, the previous studies either excluded older adults who have exercise habits or lack of information about participants' daily activity levels. Besides, all the group spine exercise interventions in previous studies were delivered by professional trainers or physical therapists in the form of face-to-face exercise classes.

The exercise protocol used by the current RCT was based on that developed by Katzmen and team. The previous studies using the same protocol reported three to five degrees decrease in the angle of kyphosis. Current RCT provides kyphosis-specific exercise in the form of short video and face to face exercise classes. The intervention of the proposed study contains two parts. One is the group kyphosis-specific exercise class given by a certified physical trainer. Another is the home practice following kyphosis-specific exercise videos. The intervention arrangement is : 1. Group learning and practice: a 1-hour kyphosis-specific exercise training session will be provided two times in the first week; 2. Weekly follow-up: a 1-hour kyphosis-specific exercise will be conducted with reinforcement of learning and remedial teaching by a certified physical trainer once a week for five consecutive weeks after the group learning and practice; 3. Self-practice: the participant will following the kyphosis-specific exercise videos doing self-practice every day for the whole intervention period lasting 6 weeks.

The group kyphosis-specific exercise class will be led by a licensed physical trainer and a trained assistant. The participant to instructor (assistant) ratio will no less than 5:1. The content of kyphosis-specific exercise videos is the same as an exercise class.

研究设计

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

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 60 years and above;
  • No cognitive impairment or communication problems;
  • The angle of thoracic kyphosis > 40° measured by Manual Inclinometer;
  • Able to decrease the angle of kyphosis of 5° while standing.

排除标准

  • Having central or peripheral neuropathy (this may affect balance);
  • Taking drugs that affect the nervous system or affect balance and strength;
  • Having untreated severe heart and lung disease (this may affect cardiopulmonary function);
  • Having a history of spinal fracture (this may increase the risk of injury);
  • Having surgery in spinal, shoulder, and pelvis in the past year or having plan to do so in the coming six month (this may increase the risk of injury);
  • Having scoliosis ≥ 10°;
  • Having done any specific therapeutic exercise for posture in the past year or having plan to do so in the coming six month (may affect the study result).

结局指标

主要结局

The change of the angle of kyphosis in degrees

时间窗: Baseline and after six weeks' intervention

Measured by manual inclinometer which have previously demonstrated excellent levels of inter-rater (ICC=0.90), and intra-rater reliability (ICC=0.92), and satisfied concurrent validity (r=0.86).

次要结局

  • The time change of up and go by seconds (Balance)(Baseline and after six weeks' intervention)
  • The bust change in breathing by centimeters (Cardiopulmonary function)(Baseline and after six weeks' intervention)
  • The distance change of walking by meters (Cardiopulmonary function)(Baseline and after six weeks' intervention)
  • The time change of one leg standing in seconds (Balance)(Baseline and after six weeks' intervention)
  • The gait performance change by gait score(Baseline and after six weeks' intervention)

研究者

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

Ms Weiying Li

Principal Investigator

The University of Hong Kong

研究点 (2)

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