NCT05899062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2024

Completed
Last Updated

September 2, 2025

Status Verified

June 1, 2023

Enrollment Period

12 months

First QC Date

June 2, 2023

Last Update Submit

August 25, 2025

Conditions

Keywords

ConstipationTelerehabilitationExerciseQuality of lifeConstipation symptoms

Outcome Measures

Primary Outcomes (1)

  • Bristol Stool Form Scale

    Visual sampling is used to obtain information about the consistency, thickness and amount of stool by specifying 7 different types of stool. In this way, rough information about both bowel work and defecation function is obtained.

    2 Minutes

Secondary Outcomes (1)

  • Constipation Assessment Scale

    5 Minutes

Other Outcomes (4)

  • Constipation Severity Scale (CSS)

    10 Minutes

  • Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire

    10 Minutes

  • 12-Item Short Form Survey (SF-12)

    5 Minutes

  • +1 more other outcomes

Study Arms (2)

Control group

OTHER

The patients in the control group will be given education about constipation, which lasts about 45-60 minutes, with the telerehabilitation method. In addition, a "Constipation Training Booklet" will be sent via e-mail or WhatsApp, related to the training content given to all patients and to reinforce the training. Definition of constipation in education, its causes, medications that cause constipation, risk factors, suggestions for prevention of constipation (such as regular defecation, not delaying defecation, best position for defecation, not straining for a long time), constipation treatment and the importance of individual management, healthy and balanced diet, nutrition Types, adequate fluid intake, benefits of exercise and appropriate exercise selection, abdominal massage, toilet training and individual methods of preventing constipation will be included.

Other: Education with the telerehabilitation method. In addition, a "Constipation Training Booklet" will be sent via e-mail or WhatsApp

Intervention group

OTHER

The patients in intervention group will be given an exercise program in addition to all the practices in the control group. Training and exercise practices will be carried out with the telerehabilitation method. Exercise training, which will last 40-60 minutes, 3 days a week for 4 weeks, will consist of warm-up and breathing exercises, exercises for constipation and cooling movements. Patients will be asked to walk for at least 30 minutes, 2 days a week, on days without exercise training.

Other: Training and exercise practices with the telerehabilitation method.

Interventions

The patients in the control group will be given education about constipation, which lasts about 45-60 minutes, with the telerehabilitation method. In addition, a "Constipation Training Booklet" will be sent via e-mail or WhatsApp, related to the training content given to all patients and to reinforce the training. Definition of constipation in education, its causes, medications that cause constipation, risk factors, suggestions for prevention of constipation (such as regular defecation, not delaying defecation, best position for defecation, not straining for a long time), constipation treatment and the importance of individual management, healthy and balanced diet, nutrition Types, adequate fluid intake, benefits of exercise and appropriate exercise selection, abdominal massage, toilet training and individual methods of preventing constipation will be included.

Control group

The patients in this group will be given an exercise program in addition to all the practices in the control group. Training and exercise practices will be carried out with the telerehabilitation method. Exercise training, which will last 40-60 minutes, 3 days a week for 4 weeks, will consist of warm-up and breathing exercises, exercises for constipation and cooling movements. Patients will be asked to walk for at least 30 minutes, 2 days a week, on days without exercise training.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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,
  • +1 more criteria

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ConstipationMotor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Raziye Şavkın, Assoc. Prof.

    Pamukkale University

    STUDY CHAIR
  • Ömer Faruk Can, PT

    Pamukkale University

    PRINCIPAL INVESTIGATOR
  • Ufuk Kutluana, Assoc. Prof.

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 12, 2023

Study Start

June 1, 2023

Primary Completion

May 27, 2024

Study Completion

May 27, 2024

Last Updated

September 2, 2025

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations