NCT06354855

Brief Summary

In this study, it will be investigated whether a daily 30-minute walk or abdominal breathing exercise is more effective on chronic constipation.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 15, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

February 28, 2024

Last Update Submit

April 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    In order to determine the severity of constipation and the degree of impact of their current situation on their lives, individuals will be asked to mark a suitable point on a horizontal line with an actual length of 10 cm. In terms of the impact of the current situation on my life, "0" means it has no impact on my life, and "10" means living like this is unbearable.

    two months

Secondary Outcomes (1)

  • Constipation Severity Scale (CSS)

    two months

Other Outcomes (1)

  • Chronic Constipation Quality of Life Scale

    two months

Study Arms (2)

Group is doing breathing exercises while watching videos

ACTIVE COMPARATOR

Abdominal breathing exercise group .The group, which receives abdominal breathing exercise training, will perform video-assisted breathing exercises for 30 minutes a day.

Other: Group is doing breathing exercises while watching videos

Medium pace walking group

ACTIVE COMPARATOR

Medium pace walking group .Control group will walk at a moderate pace for 30 minutes daily.

Other: Medium pace walking group

Interventions

Group is doing breathing exercises while watching videos: A video consisting of 30-minute exercises will be shot for these patients. And each patient will be asked to do the breathing exercise for 30 minutes by watching this video.

Group is doing breathing exercises while watching videos

Medium pace walking group: 30 minutes daily. Walking at a moderate pace is required. Physical activity levels will be monitored with the ActiGraph GT3X+ Accelerometer.

Medium pace walking group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to speak and understand Turkish,
  • Voluntarily accepted to participate in the research and written consent form was obtained (those who could fill out the forms themselves using their hands, and those who could not use it, from their relatives with verbal consent),
  • At least 18 years of age and over,
  • Oriented to place, person and time,
  • Patients who do not have spinal cord injury, parapilegia, or quadriplegia that may physiologically impede the individual's intestinal excretion Does not have any problems that prevent cognitive, sensory and verbal communication,
  • Patients who are conscious and not using any sedating medication
  • men and women aged 20-80 at the time of approval

You may not qualify if:

  • pregnancy or possible pregnancy;
  • the habit of doing all kinds of breathing exercises;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nezahat Keleşoğlu Health Sciences Necmettin Erbakan University

Konya, Meram, 42000, Turkey (Türkiye)

Location

Study Officials

  • Fatma Erdeo, Ph D

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assignment of people to groups will be done by a statistician, apart from the research using a computer program. Randomization will be determined by entering the total number of cases through the program whose URL address is https://www.randomizer.org.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups with a conventional therapy control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor, phd

Study Record Dates

First Submitted

February 28, 2024

First Posted

April 9, 2024

Study Start

February 15, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations