Clinical trial NCT05899062: Telerehabilitation-based Exercise Training in Constipated Patients
Official title: Investigation of the Effect of Telerehabilitation-based Exercise Training on Constipation Symptoms and Quality of Life.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Keywords: Constipation
Telerehabilitation
Exercise
Quality of life
Constipation symptoms
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It has been determined that three out of every four people in the society do not have sufficient physical activity level, and 54% of individuals between the ages of 15-19 and over 55 are sedentary. As a result of this, the probability of encountering the problem of constipation may increase. There are many methods in the treatment of constipation. When examined in terms of exercise interventions, it was found that 150 minutes of moderate-intensity exercise per week was effective in reducing the symptoms of constipation, while aerobic exercise performed less than 140 minutes/week did not improve the symptoms of constipation. It has been reported that individuals who received defecation training were particularly successful in the management of constipation symptoms.

In our study, it is aimed to examine the effectiveness of exercise interventions for constipation. In addition, to the best of our knowledge, no study has been conducted on the effectiveness of a telerehabilitation-based education and exercise program in patients with constipation. It is thought that the management of patients with constipation with telerehabilitation will ease the burden on the health system, while it will save the patient cost and time, and will facilitate the access to treatment for patients living in geographically disadvantaged areas. In addition, it is important for patients to participate in distance rehabilitation studies in their professional and social lives, as it is an innovative treatment approach. It is thought that the exercises for constipation applied in addition to the training program may be a more effective method in improving the quality of life and colonic motility of the patients.

Detailed description: Constipation is the problem of insufficient defecation caused by individual factors and is defined as less than three defecations per week according to health professionals. In chronic constipation, decreased frequency of defecation, hard stool, feeling of incomplete excretion of feces and straining are seen. From a biopsychosocial point of view, it negatively affects the health-related quality of life of the individual and is a health problem seen at a high rate in the society (Lembo and Camilleri 2003, Talley 2004). This situation is seen as a result of aging and affects women 2-3 times more than men (Huang et al. 2017). The incidence of constipation is seen at a rate of 22-40% in our country, in other nations is seen at a rate varies between 2 and 34%. (Kasap and Bor 2006, Uysal et al. 2010). Its etiology is multifactorial; It may occur as a result of metabolic disorders, drugs used, stress, perianal dysfunctions and other reasons (Heidelbaugh et al. 2021).

While pharmacological treatment agents such as laxatives, chlorine channel activators and osmotic agents are used in the treatment of chronic constipation, lifestyle recommendations including diet, probiotics and physical activity are also used. In some chronic cases, surgical methods are preferred (Leung et al. 2011). Some of the physiotherapy interventions used in the management of constipation are: Biofeedback, tens, interference flow and exercise (LaCross et al. 2022). It is reported that especially exercise is effective in reducing the symptoms of constipation (Gao et al. 2019).

In a study examining the effects of exercise and patient education on constipation, it was reported that regular walking for 20-30 minutes a day for 12 weeks could improve constipation symptoms (Yi et al. 2014). It has been found that 150 minutes of moderate-intensity exercise per week is effective in reducing constipation symptoms, while aerobic exercise performed less than 140 minutes/week does not reduce symptoms of constipation (De Schryver et al. 2005). It is also reported that individuals who receive defecation training are successful in managing their constipation symptoms (Ruitong Gao et al. 2019). Therefore, it is thought that lifestyle education and exercise may be effective in the management of constipation symptoms.

It has been specified that three out of every four people in the society do not have sufficient physical activity level, and especially 54% of individuals between the ages of 15-19 and over 55 are sedentary. This sedentary lifestyle and decreased physical activity may cause constipation by negatively affecting the colonic transit time (Active Living Association 2010, De Schryver et al. 2005). It has been reported that the exercise and nutrition program reduces the use of laxatives while eliminating the symptoms of constipation in patients (Ceren Orhan et al 2015). Similarly, daily moderate-intensity exercise was found to reduce constipation symptoms by 44% in women (Dukas et al. 2033).

Lack of exercise may predispose the individual to neurological diseases or musculoskeletal disorders. As a result, symptoms of abdominopelvic dyssynergia and constipation occur over time. In the treatment, it is aimed to optimize the motor coordination of the abdominal and anal muscles (Wilson 2020, Grimes 2022). Physiotherapists are effective in organizing the muscles and directing the internal pressure with the help of exercise methods in these dysfunctions. Thus, colonic transition is facilitated; while the rectum contracts, the anal sphincters can relax in time (De Schryver et al 2005).

In addition, the use of exercise programs that provide vibration in the abdominal region can cause contractions in the abdominal muscles.It is thought that this may be effective in reducing the symptoms of constipation by inducing colonic movements (Peters HP and De Vries 2001).

Physiotherapy and rehabilitation interventions, especially exercise therapy, are recommended in the treatment of constipation. However, individuals who live in remote or rural areas or cannot allocate time for such treatments due to factors such as working conditions, workplace permission problems, time and distance may find it difficult to access treatment. A possible solution in this context is to provide remote rehabilitation services with the help of telerehabilitation technology (Russell 2009). Telerehabilitation is the provision of remote rehabilitation service with the help of digital technology. Through such services, education can be provided to the patients and family members. In addition, telerehabilitation may include patient evaluation, diagnosis, treatment and follow-up of the prognosis. Thanks to tele-rehabilitation, patients living in geographically disadvantaged areas have the opportunity to access rehabilitation. As a result, the burden on the health system is reduced and time and transportation costs are saved for the patient.It may also provide additional benefits related to rehabilitation in patients' own occupational and social environments (Russell et al. 2011). As far as investigators know, there is no study on telerehabilitation enforcement in the management of constipation in the literature.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old,
* Diagnosed with constipation
* Fewer than three defecations per week
* Straining in more than 25% of defecations
* Lumpy or hard stools in more than 25% of defecations
* Sensation of incomplete emptying of stool in more than 25% of defecations
* More than 25% of defecations have a feeling of being stuck or blocked
* Requirement of manual maneuvering to facilitate at least 25% of defecations (e.g. finger emptying, support of the pelvic floor muscles)
* Rarely loose stools without the use of laxatives
* Those who have insufficient criteria for irritable bowel syndrome,
* Being sedentary (doing 30 minutes or less of moderate physical activity most days of the week),
* Those who have not participated in diet control/weight reduction programs in the last 6 months,
* To be able to understand, speak and write Turkish,
* To be able to understand the verbal and written information given,
* Having internet access,
* To be able to use video conferencing software.

Exclusion Criteria:

* Those who use drugs that affect defecation other than laxatives,
* Patients who have had previous digestive system surgery,
* Those who will undergo abdominal surgery,
* Those who have undergone major surgery in the abdominal and perianal region,
* Those with congenital megacolon, pseudoobstruction and anorectal disease,
* Those with any orthopedic limitations,
* Those with comorbid diseases such as cancer,
* Those with neurological diseases that cause functional disability,

Primary outcomes:
measure: Bristol Stool Form Scale
timeFrame: 2 Minutes
Secondary outcomes:
measure: Constipation Assessment Scale
timeFrame: 5 Minutes
Other outcomes:
measure: Constipation Severity Scale (CSS)
timeFrame: 10 Minutes
measure: Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire
timeFrame: 10 Minutes
measure: 12-Item Short Form Survey (SF-12)
timeFrame: 5 Minutes
measure: PHYSICAL ACTIVITY SCALE-2
timeFrame: 5 Minutes
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Raziye Şavkın, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Pamukkale University
name: Ömer Faruk Can, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Ufuk Kutluana, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Pamukkale University
name: Nihal Büker, Prof.
role: PRINCIPAL_INVESTIGATOR
References: