A Multimodal Wearable Device-based Study to Evaluate the Efficacy of an Exercise Prescription Intervention in IBD

NCT06427135 | Not Yet Recruiting

• 1 other identifier: WDRY2024-K058
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project is a multimodal wearable device-based evaluation of the efficacy of an exercise prescription intervention for inflammatory bowel disease in a This is a single-center, randomized controlled clinical study to evaluate the efficacy of an exercise prescription intervention in inflammatory bowel disease based on multimodal wearable devices. The experimental group was treated with exercise intervention therapy on top of the existing medication.

Conditions

Inflammatory Bowel Diseases

Keywords

Exercise interventions; Inflammatory Bowel Diseases; Wearable Device

Outcome Measures

Primary Outcomes (1)

• skeletal muscle mass index

  Changes in skeletal muscle mass index (SMI) were detected using a body composition analyzer, and were considered statistically significant if they were higher in the intervention group than in the control group (P \< 0.05);Skeletal muscle mass index is calculated as the ratio of limb skeletal muscle mass (kg) to height (m) in kg/m\^2.

  Weeks 0, 4, 8, 12 and 16 of treatment

Secondary Outcomes (8)

• Quality of life rating

  Weeks 0, 4, 8, 12 and 16 of treatment

• Psychological assessment

  Weeks 0, 4, 8, 12 and 16 of treatment

• Fatigue status assessment

  Weeks 0, 4, 8, 12 and 16 of treatment

• body fat percentage

  Weeks 0, 4, 8, 12 and 16 of treatment

• muscle power

  Weeks 0, 4, 8, 12 and 16 of treatment

Study Arms (2)

Exercise interventions

EXPERIMENTAL

Adding exercise intervention therapy to existing medications

Behavioral: Exercise interventions

Conventional drug therapy

NO INTERVENTION

No exercise intervention, use of existing medication.

Interventions

Exercise interventions BEHAVIORAL

Rehabilitation physician or rehabilitation therapist, to engage in physical exercise or patients, according to the medical examination data (including exercise test and physical strength test), according to their health, physical strength, and cardiovascular function status, with the form of a prescription for the type of exercise, intensity of exercise, exercise time and frequency of exercise, to put forward the precautions to be taken during exercise.

Exercise interventions

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Commitment to comply with the study procedures and cooperate in the implementation of the full study
• Age ≥ 18 years old, gender is not limited
• Muscle strength examination of all four limbs is greater than or equal to grade 3
• Patients with a diagnosis of CD or UC in combination with clinical presentation, laboratory examination, endoscopy, imaging and histopathologic examination, with a disease course in mild to moderate activity or remission
• Presence of low or high BMI, malnutrition, muscular dystrophy, and anxiety
• Voluntarily sign a written informed consent

You may not qualify if:

• Absolute contraindications to exercise: acute stages of various diseases (e.g. cerebral hemorrhage, acute stage of myocardial infarction), severe complications, severe cardiopulmonary dysfunction, severe gastrointestinal problems (e.g. gastric perforation, intestinal obstruction), severe locomotor system disorders (e.g. severe bone fracture), as well as other diseases that are not under effective control
• Relative contraindications to exercise: severe hypertension, severe diabetes, chronic pain, cardiac arrhythmia, etc
• Persons with unstable vital signs
• Presence of cognitive, communication disorders
• Patients who have recently undergone gastrointestinal surgery (\<1 month) or who have not fully healed
• Short bowel syndrome
• Presence of extra-intestinal manifestations and complications that interfere with therapy, such as retinopathy, deep vein thrombosis, etc
• Pregnant or lactating women
• Other potential subjects who are not suitable for participation in this study

Sponsors & Collaborators

• Ping An: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ping An

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping An

CONTACT

+8618627068700; anping_05@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This is a prospective randomized controlled study divided into intervention and control groups.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 23, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share