Effects of Different Physiotherapy Programs on Functional Constipation

NCT04710654 | Completed

• 1 other identifier: 01.12.2020-E.13987
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Constipation

Keywords

functional constipation; connective tissue manipulation; interferential current stimulation; exercise; behavioural therapy; conservative treatment

Outcome Measures

Primary Outcomes (2)

• change in severity and symptoms of constipation

  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.

  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.

• change in quality of life

  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.

  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.

Secondary Outcomes (4)

• 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.

• 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.

• treatment satisfaction

  The end of the four-week intervention program

• stool consistency

  At the baseline, the end of the four-week intervention program and after one month intervention period.

Study Arms (4)

Control

OTHER

1. Behavioural therapy 2. Exercise program

Other: behavioural therapy; Other: exercise program

connective tissue manipulation

ACTIVE COMPARATOR

Other: connective tissue manipulation; Other: behavioural therapy; Other: exercise program

Interferential current stimulation (100 Hz frequency)

ACTIVE COMPARATOR

Other: Interferential current stimulation (100 Hz frequency); Other: behavioural therapy; Other: exercise program

Interferential current stimulation (0-100 Hz frequency)

ACTIVE COMPARATOR

Other: Interferential current stimulation (0-100 Hz frequency); Other: behavioural therapy; Other: exercise program

Interventions

connective tissue manipulation OTHER

Individuals in CTM group, will sit on a stool with hips and knees flexed at 90° and their hands free on the thighs. The application will start from the basic area in the first session, and in the other sessions, the lower thoracic, scapular, inter-scapular and cervical regions will be included in the treatment as soon as possible according to the state of the vascular reaction. CTM will be applied three days a week, for four weeks.

Also known as: behavioural therapy, exercise program

connective tissue manipulation

Interferential current stimulation (100 Hz frequency) OTHER

The four electrodes (superficial, self-adhesive, 5x9 cm rectangular) coming out of the two channels will be used. Two of the electrodes will be placed bilaterally at the level of the spinal segment, T9-L2, where the sympathetic fibers of the gastrointestinal tract are innervated, in the posterior region, and the other two will be placed anteriorly on the umbilicus lateral to the abdomen. The current will be applied at the sensory level, increasing to the extent that the patient feels the current effectively but does not reveal pain, discomfort and visible muscle contractions. The application will be made to the individuals at 100 Hz frequency three days a week, for four weeks.

Also known as: behavioural therapy, exercise program

Interferential current stimulation (100 Hz frequency)

Interferential current stimulation (0-100 Hz frequency) OTHER

The four electrodes (superficial, self-adhesive, 5x9 cm rectangular) coming out of the two channels will be used. Two of the electrodes will be placed bilaterally at the level of the spinal segment, T9-L2, where the sympathetic fibers of the gastrointestinal tract are innervated, in the posterior region, and the other two will be placed anteriorly on the umbilicus lateral to the abdomen. The current will be applied at the sensory level, increasing to the extent that the patient feels the current effectively but does not reveal pain, discomfort and visible muscle contractions. The application will be made to the individuals at 0-100 Hz frequency three days a week, for four weeks.

Also known as: behavioural therapy, exercise program

Interferential current stimulation (0-100 Hz frequency)

behavioural therapy OTHER

The behavioral therapy includes patient education (description of the disease, symptoms, risk factors, treatment, defecation mechanism and informing about negative attitudes and behaviors towards defecation), lifestyle advices (diet, water consumption, fiber food, etc.), teaching effective defecation posture, timed toilet training, self-abdominal massage. "Constipation Behavioral Therapy Booklet" will be prepared within the scope of behavioral therapy.

Control; Interferential current stimulation (0-100 Hz frequency); Interferential current stimulation (100 Hz frequency); connective tissue manipulation

exercise program OTHER

Exercise program consisting of physical activity, core stabilization exercises and pelvic floor muscle exercises. "Exercise Program Booklet" will be prepared within the exercise training.

Control; Interferential current stimulation (0-100 Hz frequency); Interferential current stimulation (100 Hz frequency); connective tissue manipulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Semiha Yenişehir

Muş, 49000, Turkey (Türkiye)

Location

Related Publications (5)

• Vriesman MH, Koppen IJN, Camilleri M, Di Lorenzo C, Benninga MA. Management of functional constipation in children and adults. Nat Rev Gastroenterol Hepatol. 2020 Jan;17(1):21-39. doi: 10.1038/s41575-019-0222-y. Epub 2019 Nov 5.

  PMID: 31690829 BACKGROUND

• Moore JS, Gibson PR, Burgell RE. Randomised clinical trial: transabdominal interferential electrical stimulation vs sham stimulation in women with functional constipation. Aliment Pharmacol Ther. 2020 Apr;51(8):760-769. doi: 10.1111/apt.15642. Epub 2020 Mar 3.

  PMID: 32128859 BACKGROUND

• Sharifi-Rad L, Ladi-Seyedian SS, Manouchehri N, Alimadadi H, Allahverdi B, Motamed F, Fallahi GH. Effects of Interferential Electrical Stimulation Plus Pelvic Floor Muscles Exercises on Functional Constipation in Children: A Randomized Clinical Trial. Am J Gastroenterol. 2018 Feb;113(2):295-302. doi: 10.1038/ajg.2017.459. Epub 2017 Dec 19.

  PMID: 29257143 BACKGROUND

• Gursen C, Kerem Gunel M, Kaya S, Kav T, Akbayrak T. Effect of Connective Tissue Manipulation on Symptoms and Quality of Life in Patients With Chronic Constipation: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2015 Jun;38(5):335-43. doi: 10.1016/j.jmpt.2015.06.003. Epub 2015 Jun 20.

  PMID: 26099205 BACKGROUND

• Silva CA, Motta ME. The use of abdominal muscle training, breathing exercises and abdominal massage to treat paediatric chronic functional constipation. Colorectal Dis. 2013 May;15(5):e250-5. doi: 10.1111/codi.12160.

  PMID: 23375005 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Behavior Therapy; Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• SEMİHA YENİŞEHİR

  Muş Alparslan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 9, 2021
• First Posted: January 15, 2021
• Study Start: May 1, 2021
• Primary Completion: July 16, 2022
• Study Completion: August 16, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)