Cystic Fibrosis Core Strengthening and Respiratory Exercise Program

NCT00751647 | Completed Phase 2

• 1 other identifier: 0807-068
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to determine the short-term effects of a customized Core Strengthening and Respiratory Exercise Program (CSREP) on children with cystic fibrosis (CF) between the ages of 10 and 21 who are receiving outpatient care at Children's Hospitals and Clinics of Minnesota. The CSREP, which will be provided by a physical therapist and a physical therapist assistant, consists of specific breathing techniques and core strengthening exercises, designed to improve rib cage mobility, pulmonary function, aerobic capacity, posture, and core strength. Currently the CF population at Children's receives physical therapy on an inpatient basis only. The overall goal of this program is to prove the viability of an outpatient exercise program for this population. Specific aims include:

• To customize a CSREP protocol per each patient
• To measure patient outcomes at baseline and six months
• To develop a satisfaction tool in order to measure patient experience and satisfaction

Conditions

Cystic Fibrosis

Keywords

CF

Outcome Measures

Primary Outcomes (1)

• Pulmonary function, aerobic capacity, rib cage mobility, posture, and core strength, thus warranting more extensive study and development.

  6 months

Study Arms (1)

A1

OTHER

Population receiving the CF specific outpatient PT services.

Other: Physical Therapy

Interventions

Physical Therapy OTHER

Treatment

A1

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with cystic fibrosis receiving outpatient care from Children's Cystic Fibrosis Clinic
• Aged 10-21
• Living within a 35-mile radius of Children's Minneapolis, who agree to participate.

You may not qualify if:

• Children with co-morbid conditions in which the exercise program is contra-indicated will be excluded from this study.

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Katie Fenlon, PT

  Children's Hospitals and Clinics of MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2013
• Last Updated: February 14, 2014

Record last verified: 2014-02

Locations

US (1)