Effect of Respiratory and Relaxation Training Added to Complex Decongestive Therapy on Functional Capacity and Muscle Oxygenation in Patients With Lower Extremity Lymphedema: A Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Muscle Oxygen Saturation
研究概览
简要总结
This randomized controlled trial aims to investigate the effectiveness of respiratory and relaxation training added to standard complex decongestive therapy (CDT) on muscle oxygenation, functional capacity, and limb volume in patients with lower extremity lymphedema. Participants will be randomly assigned to receive either standard CDT alone or CDT combined with respiratory and relaxation exercises. Outcomes will be assessed before treatment, immediately after treatment, and two months after completion.
详细描述
Lower extremity lymphedema is a chronic condition characterized by impaired lymphatic drainage, limb swelling, pain, reduced physical function, and decreased quality of life. Complex decongestive therapy (CDT) is considered the gold standard treatment; however, additional interventions that may improve physiological and functional outcomes remain under investigation.
Respiratory exercises may facilitate lymphatic return through changes in intrathoracic pressure, whereas relaxation training may reduce sympathetic activation and improve exercise tolerance. Despite these theoretical benefits, there is limited evidence regarding their combined effect on muscle oxygenation in patients with lower extremity lymphedema.
Therefore, this randomized controlled study will evaluate whether adding respiratory and relaxation training to CDT improves muscle oxygenation measured by wearable near-infrared spectroscopy (MOXY), functional capacity assessed with the Six-Minute Walk Test, and limb volume compared with CDT alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and treating physiotherapists cannot be blinded because of the nature of the intervention. However, the outcome assessor responsible for collecting all outcome measures, including muscle oxygenation, functional capacity, and limb volume, will be blinded to group allocation. Participants will be instructed not to disclose their treatment assignment to the assessor. Data analysis will be performed using coded group assignments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 years or older.
- •Clinically diagnosed with secondary lower extremity lymphedema.
- •Presence of lower extremity lymphedema for at least 3 months.
- •Able to stand and walk independently to complete the Six-Minute Walk Test.
- •Willing and able to provide written informed consent.
排除标准
- •Acute cellulitis or other active infection within the previous 2-4 weeks.
- •Current or recent deep vein thrombosis (DVT) or uncontrolled peripheral vascular disease.
- •Severe cardiovascular, pulmonary, orthopedic, or neurological conditions that could interfere with participation or outcome assessments.
- •Pregnancy.
- •Skin lesions or irritation preventing placement of the near-infrared spectroscopy (MOXY) sensor.
- •Inability to comply with the study protocol or follow-up assessments.
研究组 & 干预措施
Respiratory and relaxation
Participants in this group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises, together with respiratory and relaxation training. Respiratory and relaxation exercises will be performed for approximately 10-20 minutes following each CDT session over 15 treatment sessions. Participants will also perform a daily home exercise program.
干预措施: Complex Decongestive Therapy (Other)
Respiratory and relaxation
Participants in this group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises, together with respiratory and relaxation training. Respiratory and relaxation exercises will be performed for approximately 10-20 minutes following each CDT session over 15 treatment sessions. Participants will also perform a daily home exercise program.
干预措施: Respiratory and Relaxation Training (Other)
Complex Decongestive Therapy
Participants in this group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises for 15 treatment sessions.
干预措施: Complex Decongestive Therapy (Other)
结局指标
主要结局
Change in Muscle Oxygen Saturation
时间窗: Baseline, immediately after 15 treatment sessions, and 2-month follow-up
Muscle oxygen saturation will be assessed using a wearable near-infrared spectroscopy device placed over the vastus lateralis muscle. SmO₂ values will be recorded before, during, and after the Six-Minute Walk Test.
次要结局
- Change in Six-Minute Walk Test Distance(Baseline, immediately after 15 treatment sessions, and 2-month follow-up)
- Change in Lower Extremity Limb Volume(Baseline, immediately after 15 treatment sessions, and 2-month follow-up)
研究者
Idil Esin Unlu
Asst. Prof.
Toros University