Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 主要终点
- Change from the Spanish Fibromyalgia Impact Questionnaire (SFIQ) at post intervention (week 6)
研究概览
简要总结
This study analyze the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme improving quality of life of subjects with Fibromyalgia.
详细描述
Objective:
This study investigated the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme for the improvement of the quality of life of subjects with Fibromyalgia.
Design:
A single-blind randomized clinical controlled trial.
Setting:
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)
盲法说明
Neither the participants nor their therapists were blind to the treatment allocation. However, the assessor was independent to the study and was not aware of the treatments applied or the objective of the therapy.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women between 30 and 65 years old,
- •diagnosed with Fibromyalgia by a specialized physician,
排除标准
- •The exclusion criteria were to present any limitation of mobility due to Fibromyalgia or other pathology, previous practice or knowledge of Qi gong, to be under Physiotherapy treatment and to practice any physical exercise.
结局指标
主要结局
Change from the Spanish Fibromyalgia Impact Questionnaire (SFIQ) at post intervention (week 6)
时间窗: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
SFIQ measures the level of quality of life of subjects with Fibromyalgia with a score of 0 to 100. A higher score indicates more impact of the condition on the life of the person and therefore less quality of life.
Changes from the values registered by the Spirobank-G (MIR)® spirometer
时间窗: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Spirometry measures respiratory values being the reference values (Knudson model) for a 50 year old woman with 1,65 cm of height and 65 kilos weight: FVC (Forced vital capacity)= 3.611, FEV1 (Forced expiratory volume) = 2.7505, FEV1%= 76.17%, FEF (Forced expiratory flow) 25-75%= 2.625, PEF (peak expiratory flow)= 6.222
Change from the centre of gravity registered with Wii-fit Nintendo®
时间窗: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Centre of gravity is measured in percentage through posturography study. A higher percentage means better balance
Change from the monopodal stance test registered with Wii-fit Nintendo®
时间窗: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Monopodal stance test measures static balance in percentage through posturography study. It is measure in percentage from 0 to 100 and a higher percentage means a better result.
Change from Visual Analogue Scale (VAS) at post intervention (week 6)
时间窗: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
The Visual analogue scale measures the level of pain with a score of 0 to 10 where 0 indicates no pain and 10 indicates maximun pain.
Change from Borg Scale of perceived exertion at post intervention (week 6)
时间窗: Baseline (week 0), pre intervention (week 1) and post intervention (week 6).
Borg scale measures the perceived exertion of a subject with a score of 0 to 10 where 0 is the minimum exertion and 10 is the maximun exertion.
次要结局
- Change from range of movement measured with goniometer(Baseline (week 0), pre intervention (week 1) and post intervention (week 6).)
- Change from muscle strength measured with Lovett scale(Baseline (week 0), pre intervention (week 1) and post intervention (week 6).)
- Change from flexibility measured with the Wells y Dillon scale(Baseline (week 0), pre intervention (week 1) and post intervention (week 6).)
研究者
Abel Mejías Gil
PHYSIOTHERAPIST
University of Extremadura