A Prospective, Three-Arm, Assessor-Blinded Randomized Controlled Trial Comparing Upper Body Exercise, Combined Non-Weight Bearing Exercise, and Standard Care for Improving Cardiorespiratory Fitness and Supporting Wound Healing in Patients Undergoing Active Diabetic Foot Ulcer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Cardiorespiratory Fitness (VO₂peak)
研究概览
简要总结
This randomized controlled trial (RCT) aims to evaluate the effectiveness of two different structured exercise interventions compared to standard care during active diabetic foot ulcer (DFU) treatment. Participants will be allocated to one of three groups: Upper Body Exercise (UBE), Combined Exercise (CE), or Standard Care Control (SC). The interventions are designed to improve cardiorespiratory fitness-as measured by changes in VO₂peak-and other secondary clinical, metabolic, vascular, inflammatory, muscular, and quality-of-life outcomes while ensuring proper offloading and wound management.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Adults aged 18 years or older. Diagnosis: Confirmed diagnosis of Type 1 or Type 2 diabetes. Active DFU: Presence of a diabetic foot ulcer under active treatment, as documented by the wound care team.
- •Wound Stability: Ulcer size that meets protocol criteria (e.g., <2 cm² or ≥2 cm²) and without critical limb ischemia.
- •Ability to Exercise: Medical clearance from a physician to safely participate in unsupervised upper body and non-weight bearing exercises.
- •Compliance: Capacity and willingness to adhere to the study protocol, including scheduled exercise sessions and offloading procedures.
- •Glycemic Control: Stable glycemic control medications regimen for at least 4 weeks prior to enrollment.
- •Informed Consent: Ability to provide written informed consent.
排除标准
- •Critical DFU Complications: Ulcers with signs of critical limb ischemia, severe infection (e.g., osteomyelitis), or wound deterioration that contraindicates participation.
- •Cardiovascular Limitations: Unstable cardiac conditions (e.g., uncontrolled arrhythmias, recent myocardial infarction within 6 months), severe heart failure, or any other condition contraindicating exercise.
- •Neurological or Musculoskeletal Limitations: Conditions that significantly impair upper body or core exercise performance (e.g., severe arthritis, recent upper body injury).
- •Cognitive Impairment: Significant cognitive or psychiatric disorders that would limit the ability to provide informed consent or adhere to the intervention protocol.
- •Concurrent Participation: Enrollment in another clinical trial or exercise program that conflicts with the study protocol.
- •Other Medical Risks: Any other condition, as determined by the study physician, that places the participant at increased risk of adverse events during exercise (e.g., severe peripheral vascular disease not amenable to offloading).
研究组 & 干预措施
Upper Body Exercise Group (UBE):
Structured upper extremity and core exercise sessions while maintaining foot offloading.
干预措施: Upper Body Exercise Protocol (UBE) (Behavioral)
Combined Exercise Group (CE):
Structured non-weight bearing combined exercise including upper body, core, and modified lower extremity exercises while maintaining foot offloading.
干预措施: Combined Non-Weight Bearing Exercise Protocol (CE) (Behavioral)
Standard Care Control Group (SC):
Standard wound care without a structured exercise intervention.
干预措施: Standard Diabetic Foot Ulcer Wound Care (SC) (Behavioral)
结局指标
主要结局
Cardiorespiratory Fitness (VO₂peak)
时间窗: Baseline and at 12 weeks
Change in VO₂peak measured using arm ergometry with validated protocols designed for patients with lower extremity limitations. VO₂peak is a key indicator of cardiovascular fitness, with improvements expected in response to the structured exercise interventions.
次要结局
- Wound Healing - Percent Wound Area Reduction(4, 8, and 12 weeks)
- Wound Healing - Time to Wound Closure(Recorded weekly during the 12-week intervention)
- Wound Healing - Wound Recurrence Title(At 6-month follow-up)
- Metabolic Control - HbA1c Levels(Baseline and 12 weeks)