The Effects of Physical Activity on Patients With Inflamm... | NCT02222584

Studies
The Effects of Physical Activity on Patients With Inflammatory Bowel Disease

NCT02222584

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Mar 27, 2019Actual

Enrollment

158Actual

Phase

Not provided

Conditions

Inflammatory Bowel Disease

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Feb 2018Actual

Completion Date

Feb 2018Actual

First Submitted Date

Aug 19, 2014

First Submission Date that Met QC Criteria

Aug 20, 2014

First Posted Date

Aug 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2019

Last Update Posted Date

Mar 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Physical activity (PA) is beneficial in the prevention and management of chronic disease. However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and whether or not vigorous PA may have beneficial effects on patients' health. To evaluate the level of PA and the effect of PA on disease activity of patients with IBD. To evaluate the effect of PA on quality of life of patients with IBD.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

158Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IBD group		patients with with inflammatory bowel disease who are visiting the out-patient clinic of severance hospital from July 2014 to February 2015

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
level of physical activity (PA)	Physical activity (PA) levels were assessed using the International PA Questionnaire. Based on self-reported frequency (day) and duration (hr) of physical activities, corresponding metabolic equivalent (MET-hr/wk) values were calculated to lowest PA, low PA, moderate PA and highest PA	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 19
patients with inflammatory bowel disease (Crohn's disease, Ulcerative Colitis, intestinal behcet's disease)

Exclusion Criteria:

Age <19
Patient who denied to response the survey questions
Patient who denied to enroll the survey research

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with inflammatory bowel disease who are visiting the out-patient clinic of severance hospital from July 2014 to Feburary 2015

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital		Seoul		120-752	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D009043	Motor Activity

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided