Preoperative Home-based Exercise in Older People Before Colorectal Surgery - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
The purpose of the study is to evaluate the feasibility of recruitment procedure, intervention including compliance and the collaboration between in- and out patient clinics of preoperative home-based exercise in older people before colorectal surgery.
详细描述
The feasibility study will be conducted in order to evaluate the study design of a future RCT. Feasibility data will eg. consist of study flow description, number of eligible participants, included participants, patients and instructors satisfaction with the intervention, training compliance, reasons for drop-outs, and adverse events.
Patients waiting for colorectal surgery will be recruited and included after informed consent. Physical and respiratory function will be assessed at the hospital before the intervention, the day before surgery and the day before discharge. Data on postoperative complications, length of stay and mortality will be collected during the hospital stay. At baseline and six months after surgery, the participants will receive three questionnaires about level of independence in daily living, physical activity and health related quality of life. The intervention will be performed in the older person's home and consists of a combination of high-intensity respiratory training and individually adjusted functional exercise. Both groups will receive physical activity advice and malnutrition will be screened to optimize their nutritional status.
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)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 70, understand and speaks the Swedish language. Surgery due to cancer
排除标准
- •Health status that contradicts participation in the study such as unstable heart disease or severe orthopaedic conditions that prohibits training and severe systematic illness.
研究组 & 干预措施
Exercise group
The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
干预措施: Exercise (Other)
Control group
The participants will receive ordinary preoperative information, but will also be encouraged to follow the recommendation of 150 minutes/week of moderate physical activity.
干预措施: Exercise (Other)
结局指标
主要结局
Recruitment Rate
时间窗: Baseline
The recruitment rate is calculated by the number of participants allocated to either the exercise group or control group from the total number of eligible participants (n=66).
Exercise Compliance
时间窗: At the end of the intervention, after 2-4 weeks
Compliance with the exercise intervention was defined as the number of sessions attended out of planned sessions and was registered in the exercise logs by the physiotherapists in primary care. Only participants randomized to the exercise group were evaluated for this assessment.
Acceptability
时间窗: At the end of the intervention, after 2-4 weeks
Patients and instructors satisfaction with the intervention measured with a survey. Instructors were not enrolled. Only participants randomized to the exercise group were evaluated for this assessment.
Adverse Events
时间窗: During the intervention, after 1-4 weeks
Musculoskeletal-related events, cardiovascular episodes, falls and health care use that occurred during the exercise intervention before (pre)-surgery. Adverse events are only reported for the intervention group since the control group were a treatment as usual (TAU) group.
次要结局
- Six-minute Walk(Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery)
- Inspiratory Muscle Strength(Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery)
- Chair-stand 30-sec(Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery)
- Walking Speed(Baseline, before surgery (after 2-4 weeks), before discharge app 4-10 days after surgery)
- Postoperative Complications(Within the first 30 days of surgery)
- Length of Stay(At discharge, 2-4 weeks after baseline)
研究者
Elisabeth Rydwik
Associate professor
Karolinska Institutet