Cystic Fibrosis Core Strengthening and Respiratory Exercise Program (CSREP)

February 13, 2014 updated by: Children's Hospitals and Clinics of Minnesota

Cystic Fibrosis Core Strengthening and Respiratory Exercise Program (CSREP)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design: Phase II clinical trial.

Objective: To determine whether a customized physical therapy exercise intervention titled Core Strengthening and Respiratory Exercise Program (CSREP) clinically improves the following outcome measures for children between the ages of 10 and 21 with cystic fibrosis: pulmonary function, aerobic capacity, rib cage mobility, posture, and core strength, thus warranting more extensive study and development.

Background: Previous research conducted in pediatric populations has focused on the effects of aerobic training, anaerobic training, and strengthening of the extremities on the health of children with cystic fibrosis. However, the disease process of cystic fibrosis secondarily causes impairments in the musculoskeletal and nervous systems. No intervention study aimed at positively impacting these systems has been done to date with children with cystic fibrosis.

Methods: A 6-month CSREP will be customized to meet the specific needs of each participant. During Part I of the program participants will attend weekly CSREP treatments for 4 to 6 weeks; in Part II they will attend monthly CSREP treatments over a five-month period. Each session will last for 45-60 minutes. During these treatments, participants will be given instruction on a daily home exercise program and will receive hands on physical therapy interventions. Handouts with pictures and how-to instructions for assigned exercises will be provided. Participants will be given calendars to track completion of home exercises and level of compliance. During Part II, a researcher will call participants every week in order to encourage compliance with the home exercise program and to provide clarification as needed. All participants will continue to receive regular medical care as well as PT treatments.

A respiratory therapist will perform the pulmonary function tests, a respiratory therapist along with an exercise physiologist will perform the VO2max testing, and a physical therapist will perform the physical therapy evaluation, including assessment of rib cage mobility, core strength, and posture. Another physical therapist as well as a physical therapist assistant will provide the physical therapy treatments, instruct the participants in their home program, and make the weekly phone calls to all participants.

An experience survey will be designed to evaluate both satisfaction on a scale of 1 to 10 and self scoring of outcome measures including: respiratory function, cough strength, activity tolerance, posture, and strength on a three point Likert scale of: 1) Got worse; 2) Stayed the same; and 3) Got better. Additionally, the survey will include a question on the likelihood of continuing with the home program after the study has ended. The survey will be administered at 6 months upon completion of the program.

Relevance: The results of this inquiry as to the viability of the CSREP will prove relevant to the above-mentioned patient outcomes within the cystic fibrosis population. The customized CSREP protocol will provide a non-pharmacological outpatient treatment option that can be completed on an outpatient basis, independently, in the patient's home.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals And Clinics Of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A1
Population receiving the CF specific outpatient PT services.
Other: Physical Therapy
Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary function, aerobic capacity, rib cage mobility, posture, and core strength, thus warranting more extensive study and development.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospitals and Clinics of Minnesota

Investigators

  • Principal Investigator: Katie Fenlon, PT, Children's Hospitals and Clinics of MN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 12, 2008

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 13, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0807-068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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