Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Weekly defecation frequency
研究概览
简要总结
The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation. There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation. However, to the best of our knowledge, there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects. By combining these two approaches, we believe that a higher and broader effect (local and systemic) and perhaps a cure for constipation (reaching the ideal defecation frequency or asymptomatic status) can be achieved. Therefore, this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study. This study is designed as a randomized controlled trial.
详细描述
The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation. There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation. However, to the best of our knowledge, there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects. By combining these two approaches, we believe that a higher and broader effect (local and systemic) and perhaps a cure for constipation (reaching the ideal defecation frequency or asymptomatic status) can be achieved. Therefore, this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study. This study is designed as a randomized controlled trial. A total of 44 individuals will be randomly assigned to 2 groups. Patients in group 1 will receive patient education with abdominal massage and aerobic exercise training. Patients in Group 2 will receive only abdominal massage and patient education. Abdominal massage and aerobic exercise will be practiced 8 weeks, 3 days a week in the clinic under the supervision of a physiotherapist, and 8 weeks, 2 days a week outside the clinic. Patient education includes information about constipation and lifestyle recommendations for constipation. Physical, sociodemographic, medical and lifestyle characteristics of the individuals will be recorded as descriptive measurements. Among the descriptive characteristics, physical activity level will be assessed with the International Physical Activity Questionnaire-Short Form and the presence of diastasis recti abdominis will be assessed with the finger width test. Outcome measures of weekly defecation frequency, defecation time, laxative use frequency and average stool consistency score will be recorded by the 7-Day Bowel Diary. Stool consistency will be questioned with the Bristol Stool Scale. Other outcome measures will be severity of constipation by the Constipation Severity Scale and Constipation Scoring System, gastrointestinal symptom level by the Gastrointestinal Symptom Rating Scale, constipation-related quality of life by the Constipation Quality of Life Scale, abdominal muscle strength by the observational/manual muscle strength test, and functional exercise capacity by the 6-min walking test. All outcome measurements will be performed at baseline and at the end of the 8th week. Perception change will be assessed using the Patient Perception of Global Change Scale, and compliance with lifestyle recommendations will be assessed using the Numeric Rating Scale. The compliance of patients with exercise and massage sessions will be assessed using diaries.
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
- 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
- •Being between the ages of 18-65
- •Diagnosed with chronic constipation according to Rome IV criteria
- •No new treatment for constipation in the last 3 months
- •Absence of any condition that would prevent compliance with the interventions and assessments in the study
排除标准
- •Presence of secondary constipation ( uncontrolled metabolic disease (uncontrolled DM, hypothyroidism), hyperparathyroidism, neurologic disease or use of anticoagulants, anticholinergics, antihistamines, antipsychotics or opioids)
- •In individuals over 50 years of age, the presence of alarm symptoms (new-onset constipation, rectal bleeding, involuntary weight loss, nausea and vomiting, fever and anemia)
- •having BMI > 30 kg/m²
- •having cancer diagnosis
- •being pregnant or breastfeeding, being within the first year postnatally
- •having irritable Bowel Syndrome, Hirschprung's Disease, Crohn's Disease, Inflammatory Bowel Disease, Megacolon diagnosis, Megarectum diagnosis, Rectocele and enterocele stage 3 and above
- •presence of advanced systemic disease (e.g. cardiovascular, respiratory, renal or hepatic diseases)
- •history of abdomino-pelvic or gastrointestinal surgery in the last 6 months
- •presence of open wound, disruption of skin integrity, local tumor, cholestomy or abdominal hernia at the massage site
- •Presence of orthopedic (e.g. lumbopelvic pain, advanced knee joint degeneration) and cardiovascular diseases (e.g. acute coronary syndrome, stage 3-4 heart valve diseases) that may prevent aerobic exercise training
研究组 & 干预措施
Aerobic Exercise and Abdominal Massage
Aerobic Exercise: Aerobic exercise training will be given for 8 weeks, 3 days a week on the treadmill in the clinic under the supervision of a physiotherapist, and 8 weeks, the other 2 days a week outside the clinic. The duration of the walking session is 50 minutes (5 minutes warm-up - 40 minutes load - 5 minutes cool down).
Abdominal Massage: Abdominal massage will be performed manually by applying baby oil to the patient's abdomen and while the patient is in the supine position. This application will take approximately 15 minutes. The massage will be performed by the physiotherapist in the clinic 3 days a week for 8 weeks and by the patient outside the clinic 2 days a week for 8 weeks as self-massage.
干预措施: Aerobic Exercise (Other)
Aerobic Exercise and Abdominal Massage
Aerobic Exercise: Aerobic exercise training will be given for 8 weeks, 3 days a week on the treadmill in the clinic under the supervision of a physiotherapist, and 8 weeks, the other 2 days a week outside the clinic. The duration of the walking session is 50 minutes (5 minutes warm-up - 40 minutes load - 5 minutes cool down).
Abdominal Massage: Abdominal massage will be performed manually by applying baby oil to the patient's abdomen and while the patient is in the supine position. This application will take approximately 15 minutes. The massage will be performed by the physiotherapist in the clinic 3 days a week for 8 weeks and by the patient outside the clinic 2 days a week for 8 weeks as self-massage.
干预措施: Abdominal Massage (Other)
Aerobic Exercise and Abdominal Massage
Aerobic Exercise: Aerobic exercise training will be given for 8 weeks, 3 days a week on the treadmill in the clinic under the supervision of a physiotherapist, and 8 weeks, the other 2 days a week outside the clinic. The duration of the walking session is 50 minutes (5 minutes warm-up - 40 minutes load - 5 minutes cool down).
Abdominal Massage: Abdominal massage will be performed manually by applying baby oil to the patient's abdomen and while the patient is in the supine position. This application will take approximately 15 minutes. The massage will be performed by the physiotherapist in the clinic 3 days a week for 8 weeks and by the patient outside the clinic 2 days a week for 8 weeks as self-massage.
干预措施: Patient Education (Other)
Abdominal Massage
Abdominal Massage: Abdominal massage will be performed manually by applying baby oil to the patient's abdomen and while the patient is in the supine position. This application will take approximately 15 minutes. The massage will be performed by the physiotherapist in the clinic 3 days a week for 8 weeks and by the patient outside the clinic 2 days a week for 8 weeks as self-massage.
干预措施: Patient Education (Other)
Abdominal Massage
Abdominal Massage: Abdominal massage will be performed manually by applying baby oil to the patient's abdomen and while the patient is in the supine position. This application will take approximately 15 minutes. The massage will be performed by the physiotherapist in the clinic 3 days a week for 8 weeks and by the patient outside the clinic 2 days a week for 8 weeks as self-massage.
干预措施: Abdominal Massage (Other)
结局指标
主要结局
Weekly defecation frequency
时间窗: Change in weekly defecation frequency from 1 week before the interventions to the end of the 1st week after the interventions.
The bowel diary developed by Pamuk et al. is a widely used and practical diary that records defecation frequency, defecation duration, stool consistency, gas/fecal incontinence, pain during defecation and amount of laxative use. The 7-day bowel diary will be used to record weekly defecation frequency for a period of 1 week before the interventions and within 1 week following the end of the interventions
次要结局
- Average weekly defecation time(Change in weekly duration of defecation from 1 week before the interventions to end of the 1st week after the interventions.)
- Patient perception of global change(Patient perception of global change from baseline to the end of 8th week)
- Average weekly frequency of laxative use(Change in weekly frequency of laxative use from 1 week before the interventions to end of the 1st week after the interventions.)
- The severity of constipation(Change in the severity of constipation from baseline to end of week 8)
- Abdominal muscle strength(Change in abdominal muscle strength from baseline to the end of the 8th week)
- Average weekly stool consistency score(Change in weekly stool consistency score from 1 week before the interventions to end of the 1st week after the interventions.)
- The severity of constipation and associated discomfort(Change in severity of constipation and associated discomfort from baseline up to end of 8th week)
- Gastrointestinal symptom level(Change in gastrointestinal symptom level from baseline to the end of the 8th week)
- Constipation-related quality of life(Change in constipation-related quality of life from baseline to the end of the 8th week)
- Functional exercise capacity(Change in functional exercise capacity from baseline to the end of the 8th week)
研究者
SERAP ÖZGÜL
Prof. Dr.
Hacettepe University