WASA - Walking and Sitting Difficulties After APE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Can a specific physical online training program decrease sitting and walking difficulties 12 months after abdominoperineal excision for rectal cancer compared with standard care (self-administered aerobic training according to WHO recommendations only)?
研究概览
简要总结
Earlier studies have shown that many patients (up to 30%) who have had a major surgery for rectal cancer, called a rectum amputation (where the entire rectum and anus are removed and the person gets a permanent stoma), still have trouble sitting and walking three years after the surgery. These problems are then seen as long-term or chronic.
WASA is a randomized multicenter international study that will test a way to reduce these problems. It will start in fall 2025 and go on for 3.5 years. About 300 patients will take part.
The patients will be randomly divided into two groups. One group will get guided online training twice a week, specially made for their needs. The other group will get information about the World Health Organization's (WHO) general advice on physical activity.
The idea is that special training during the first year after surgery will reduce problems with walking and sitting. If the hypothesis can be confirmed, it could lead to an easy and low-cost way to help many rectal cancer patients feel and function better.
详细描述
Coordinating centre:
SSORG/Göteborg, Department of Surgery, Sahlgrenska University Hospital/Östra Principal Investigator: Charlotta Larsson MD, PhD Deputy Principal Investigator: Eva Haglind, MD, PhD, professor emerita Doctoral student: Lina Björklund Sand MD
Purpose and Aims:
The primary aim of the WASA trial is to evaluate the effectiveness of a structured physical activity program compared to standard WHO-based physical activity recommendations in reducing sitting and walking difficulties in patients who have undergone abdominoperineal excision (APE) for rectal cancer. The intervention secondary aims are to improve patient quality of life and reduce chronic pain and mobility issues post-surgery.
Background:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with rectal cancer to be treated with/without neoadjuvant (chemo)radiation and abdominoperineal excision with or without mesh (APE/ELAPE) Informed consent Able to read and understand Swedish or Danish
排除标准
- •Patients with rectal cancer to be operated by extended abdominoperineal excision (ELAPE) requiring musculocutaneous or muscular flaps to be operated by Hartmann's procedure to be operated by anterior resection (low or high) participation in other randomized trials in conflict with the protocol and endpoints of the WASA trial Not understanding Swedish or Danish Patients reporting habit of physical activity exceeding the WHO-recommendations (150 min + two strength sessions) at baseline.
研究组 & 干预措施
Training intervention arm
Targeted supervised training program of specific training of levator, abdominal, quadriceps (all portions), and gluteal muscles as well as endurance training.
干预措施: Targeted leaderled training program (Procedure)
Control arm
Information of training in accordance with WHO recommendations of 30 min aerobic physical activity five times per week (150 min per week) plus strength sessions twice weekly.
干预措施: Control arm with WHO recommendation on physical activity (Procedure)
结局指标
主要结局
Can a specific physical online training program decrease sitting and walking difficulties 12 months after abdominoperineal excision for rectal cancer compared with standard care (self-administered aerobic training according to WHO recommendations only)?
时间窗: 12 months
Patient reported sitting and walking difficulties by validated questions in questionnaire with items from "no difficulties" to "severe difficulties".
次要结局
- Parastomal hernia(12 months after abdominoperineal excision surgery)
- Length of hospital stay(within 12 months and 24 months of abdominoperineal excision surgery)
- Mortality(30 days, 1, 2 and 5 years)
- Health economic analysis(24 months)
- Perineal hernia(12 months after abdominoperineal excision surgery)
- Biomarkers(Baseline, 4 weeks and 12 months)
- Faecal sample(baseline, 4 weeks and 12 months)
- Cognition(baseline, 6,12 and 24 months after abdominoperineal excision surgery)
- Fatigue(6, 12 and 24 months)
- Self-reported problems with sitting and/or walking and physical activity(6 and 24 months)
- Objective tests(baseline, 6, 12 and 24 months)
- Pain(6, 12 and 24 months)
- Comprehensive Complication Index (CCI)(Within 30 and 90 days of abdominoperineal excision surgery)
- Re-admissions(Within 12 and 24 months of abdominoperineal excision surgery)
- Activities of daily life(baseline, 6,12 and 24 months)
- Bodily functions(baseline, 6, 12 and 24 months)
- Quality of life(6,12 and 24 months)
- Muscle thickness(12 months)
- Fibrosis in pelvic region(12 months)
- Degree pf physical activity(6,12 and 24 months)
- Microbiota(6 months)
- From sitting to standing(baseline, 6, 12 and 24 months)
- Walk test(baseline, 6, 12 and 24 months)
- Grip strength(baseline, 6 and 12 months)
- Reoperation(Within 12 and 24 months after abdoinomperineal escision surgery)
- Health economic analysis(24 months after abdominoperineal excision surgery)
研究者
Charlotta Larsson, MD PhD
MD PhD
Göteborg University