Effects of Body Awareness Therapy on Physical Psychosocial Outcomes in Peripheral Artery Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- 6-Minute Walk Test
研究概览
简要总结
Patients will be divided into two groups. One group will receive only a conventional physiotherapy program. The conventional physiotherapy program included breathing and aerobic exercises, energy conservation techniques, and activities of daily living. The exercises were supervised once a week and unsupervised for six days. The program was administered 1 x 7 x 8 hours/day/week.
The experimental group received Body Awareness therapy in addition to the conventional physiotherapy program. The exercise content included relaxation exercises, breathing exercises, floor exercises for trunk and pelvic movements, and extremity movements. Body Awareness Therapy was also administered 1 x 7 x 8 hours/day/week.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Peripheral Artery Disease (PAD) (confirmed by Doppler ultrasonography or Ankle-Brachial Index (ABI) ≤ 0.90).
- •Being between 40 and 75 years of age.
- •Having Stage II-III PAD.
- •Being able to walk independently or with minimal support.
- •Being fit for exercise with cardiac or pulmonary functions.
- •Having a cognitive level sufficient to participate in body awareness training.
- •Having a stable cardiovascular status (not having had an acute cardiac event, myocardial infarction, or stroke) within the last 6 months.
- •Agreeing to actively participate in the study and signing the informed consent form.
排除标准
- •Having Stage IV PAD.
- •Individuals unable to carry out daily activities due to severe rest pain.
- •Serious cardiovascular, pulmonary, neurological, cognitive, or musculoskeletal diseases
- •Those who have had a myocardial infarction, stroke, or surgery within the last 6 months.
- •Uncontrolled hypertension, heart failure, respiratory failure, or dependence on oxygen support
- •Active infection or inflammatory diseases
- •Uncontrolled diabetes or renal failure
- •Missed 2 consecutive sessions
结局指标
主要结局
6-Minute Walk Test
时间窗: Baseline
Muscle Strength
时间窗: Baseline
For Quadriceps and Hamstring muscles with hand-held dynamometer
Body Awareness Questionnaire (BAQ)
时间窗: Baseline
The total score on the scale is between 18 and 126. A high score indicates a high level of awareness.
Visual Analog Scale
时间窗: Baseline
Durnig resting, at Night and After Training. A high score indicates a high level of pain intensity.
Claudication Onset Distance
时间窗: Baseline
Absolute Claudication Distance
时间窗: Baseline
Pain Catastrophizing Scale
时间窗: Baseline
The total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.
Pittsburgh Sleep Quality Index
时间窗: Baseline
The total score ranges from 0 to 21. Higher scores reflect poorer sleep quality.
Multidimensional Scale of Perceived Social Support
时间窗: Baseline
The total score ranges from 12 to 84. Higher scores indicate greater perceived social support.
Perceived Stress Scale (PSS-10)
时间窗: Baseline
The total score ranges from 0 to 40. Higher scores indicate higher perceived stress.
Hospital Anxiety and Depression Scale
时间窗: Baseline
Each subscale (Anxiety and Depression) ranges from 0 to 21. Higher scores indicate greater anxiety or depressive symptoms.
Tampa Scale of Kinesiophobia
时间窗: Baseline
The total score ranges from 17 to 68. Higher scores indicate greater fear of movement.
6-Minute Walk Test
时间窗: End of the 8th week
Muscle Strength
时间窗: End of the 8th week
For Quadriceps and Hamstring muscles with hand-held dynamometer
Body Awareness Questionnaire (BAQ)
时间窗: End of the 8th week
The total score on the scale is between 18 and 126. A high score indicates a high level of awareness.
Visual Analog Scale
时间窗: End of the 8th week
Durnig resting, at Night and After Training. A high score indicates a high level of pain intensity.
Claudication Onset Distance
时间窗: End of the 8th week
Absolute Claudication Distance
时间窗: End of the 8th week
Pain Catastrophizing Scale
时间窗: End of the 8th week
The total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.
Pittsburgh Sleep Quality Index
时间窗: End of the 8th week
The total score ranges from 0 to 21. Higher scores reflect poorer sleep quality.
Multidimensional Scale of Perceived Social Support
时间窗: End of the 8th week
The total score ranges from 12 to 84. Higher scores indicate greater perceived social support.
Perceived Stress Scale (PSS-10)
时间窗: End of the 8th week
The total score ranges from 0 to 40. Higher scores indicate higher perceived stress.
Hospital Anxiety and Depression Scale
时间窗: End of the 8th week
Each subscale (Anxiety and Depression) ranges from 0 to 21. Higher scores indicate greater anxiety or depressive symptoms.
Tampa Scale of Kinesiophobia
时间窗: End of the 8th week
The total score ranges from 17 to 68. Higher scores indicate greater fear of movement.
次要结局
未报告次要终点
研究者
Emre Şenocak
Assistant Professor
Karadeniz Technical University