Effects of Different Physiotherapy Programs on Functional Constipation
- Conditions
- Functional Constipation
- Interventions
- Other: behavioural therapyOther: Interferential current stimulation (100 Hz frequency)Other: connective tissue manipulationOther: Interferential current stimulation (0-100 Hz frequency)Other: exercise program
- Registration Number
- NCT04710654
- Lead Sponsor
- Muş Alparlan University
- Brief Summary
This study compares the effectiveness of a more comprehensive behavioral treatment, physical activity and exercise program, as well as CTM and IF current stimulation approaches at different frequencies on functional constipation symptoms and quality of life, compared to their counterparts in the literature.
- Detailed Description
Functional constipation (FC), which is characterized by conditions such as excessive straining and difficulty in defecation, infrequent bowel movements, and incomplete defecation, is a common bowel disease that causes activity limitation and decrease in quality of life in children and adults, regardless of an organic etiology.
In the literature, there are studies showing the effectiveness of different physiotherapy approaches such as behavioral therapy, exercise, neuromodulation applications, kinesiotape, abdominal massage in FC, and investigate and compare the effectiveness of connective tissue manipulation (CTM) and interferential (IF) current stimulation applied in addition to behavioral therapy and exercise program. But there was any study which compare the effectiveness of these physiotherapy methods with each other and IF current stimulation at different frequencies (100 Hz and 0-100 Hz). In addition, there are no randomized controlled studies comparing the current effects of IF applied at 100 Hz and 0-100 Hz in individuals with FC.
The treatment methods to be applied in this study are behavioral therapy, physical activity and exercise program, CTM and IF current stimulation applied at a frequency of 100 Hz and 0-100 Hz.
The diagnostic method to be used is based on the Rome IV FC Criteria and the Bristol Stool Form Scale.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- being able to read and write in Turkish,
- being between 18 and 65 years of age
- having a diagnosis of functional constipation according to Rome IV criteria
- having body mass index <35 kg/m2
- being pregnant
- having comorbidities (chronic pelvic pain, neurological (Parkinson's, Multiple sclerosis, Spinal cord lesion, etc.), metabolic / endocrine (Diabetes Mellitus, hypercalcemia, hypothyroid, etc.), cardiorespiratory diseases
- health problems which may prevent standing from sitting, walking (orthopedic, neurological, cardiorespiratory, etc.)
- malignancy, acute inflammation, intestinal tumor
- history of gastrointestinal and pelvic surgery or spinal surgery other than cholecystectomy, appendectomy, or hysterectomy
- contraindications to Interferential Current (thrombosis, pacemaker, metal implant etc.)
- visual, auditory or cognitive problems which may prevent participation to the study
- tumor, presence of skin problems in the application area
- presence of laxative use for functional constipation in the last four weeks
- alarm symptoms (unexplained, more than 10% weight loss in 3 months, hemorrhoids and anal fissures, rectal bleeding, family history of colon cancer)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control behavioural therapy 1. Behavioural therapy 2. Exercise program connective tissue manipulation exercise program - Control exercise program 1. Behavioural therapy 2. Exercise program Interferential current stimulation (100 Hz frequency) Interferential current stimulation (100 Hz frequency) - connective tissue manipulation connective tissue manipulation - Interferential current stimulation (100 Hz frequency) behavioural therapy - connective tissue manipulation behavioural therapy - Interferential current stimulation (0-100 Hz frequency) behavioural therapy - Interferential current stimulation (100 Hz frequency) exercise program - Interferential current stimulation (0-100 Hz frequency) exercise program - Interferential current stimulation (0-100 Hz frequency) Interferential current stimulation (0-100 Hz frequency) -
- Primary Outcome Measures
Name Time Method change in severity and symptoms of constipation Participants will be applied intervention program for four weeks. Change in severity and symptoms of constipation will be assessed at the baseline, the end of the four-week intervention program and after one month intervention period. Turkish version of Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. The Constipation Severity Instrument is a 16-item patient-reported outcome measure that investigates symptoms of constipation based on frequency, severity, and bother of symptoms. CSI consists of three subscales: obstructive defecation, colonic inertia and pain.
Higher scores of CSI indicate more severe constipation.change in quality of life Participants will be applied intervention program for four weeks. Change in quality of life will be assessed at the baseline, the end of the four-week intervention program and after one month intervention period. Turkish version of Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. PAC-QOL consists a total of 28 items in four subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life.
- Secondary Outcome Measures
Name Time Method stool consistency At the baseline, the end of the four-week intervention program and after one month intervention period. The Bristol Stool Scale (BGS) will be used evaluate stool consistency. The stool form is sensitive to the change in transit time. Type 1=separate hard lumps, like nuts; Type 2= gnarled, hard sausage but lumpy; Type 3=cracks on the surface like sausage; Type 4=Soft, smooth, sausage-like; Type 5=separate soft parts; Type 7=classified as liquid without solid particles. While Types 1 and 2 indicate constipation, Types 6 and 7 inflammation, Type 3 and Type 4 are considered normal.
bowel diary Participants will be applied intervention program for four weeks. Bowel diary will be assessed at the baseline, the end of the four-week intervention program and after one month intervention period. Before and after treatment, bowel habits will be evaluated with a seven-day Bowel Diary. Intestinal diary with date and time, food/drink consumed, medication (type + amount), bowel urgency? (Rate 1 mild - 3 strong), pain and discomfort (1: mild, 3: strong), voiding time, Bristol Stool Scale Type will be recorded if there is any accident / leak.
treatment satisfaction The end of the four-week intervention program The level of satisfaction with the treatment will be evaluated with the Visual Analogue Scale (VAS). On the 10 cm long line, the starting point will be determined as 0 cm "not at all satisfied" and 10 cm poin indicated "very satisfied". The distances of the points marked on the VAS to the 0 cm point will be measured and recorded with a ruler.
physical activity level Participants will be applied intervention program for four weeks. The physical activity level will be assessed at the baseline, the end of the four-week intervention program and after one month intervention period. Turkish-International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be used to evaluate level of physcial activity of participants. The IPAQ-SF is a self-reported measure consists of seven items. It asks four intensity levels: vigorous-intensity activities, moderate-intensity activities, walking and sitting. The total score is the summation of the duration and frequency of walking, moderate-intensity, and vigorous-intensity activity. The total score was reported as "Metabolic Equivalent of Task-min/week." The sitting time is reported separately as "h/day."
Trial Locations
- Locations (1)
Semiha Yenişehir
🇹🇷Muş, Turkey