Text Size

Do Musculoskeletal Techniques Improve Forced Expiratory Volume in One Second in Adults With Cystic Fibrosis?

This study has been completed.
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00716664
First received: July 15, 2008
Last updated: March 10, 2009
Last verified: July 2008
History of Changes
  Purpose

The pilot study aims to evaluate the effects of a treatment series of gentle joint and muscle movements (in addition to normal optimal care)on lung function, exercise capacity and posture in stable adults with cystic fibrosis.


Condition Intervention
Cystic Fibrosis
 Other: A treatment series of gentle joint and muscle movements
Other: Control group measurements

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study: Do Physiotherapy Musculoskeletal Techniques Improve Forced Expiratory Volume in One Second in Adults With Cystic Fibrosis?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Forced expiratory volume in one second [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Forced vital capacity, peak expiratory flow rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Visual analogue scale for pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Modified shuttle test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The Cystic Fibrosis Quality of Life Questionnaire, section one: physical functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Flexi curve measurements of posture [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Chest wall excursion measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Full lung function will be measured ≤ one month prior to the start of the study and at the end of the intervention period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Questionnaire II - the subject's perspective [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The experimental group receives the intervention in addition to normal optimal care
 Other: A treatment series of gentle joint and muscle movements
Undertaken by a physiotherapist, weekly, for six weeks
Other Names:
  • manual therapy
  • physical therapy
  • mobilisation
  • musculoskeletal techniques
Active Comparator: 2
The active comparator, or control group, receives normal optimal care only
 Other: Control group measurements
The control group are measured using the same outcome measures at the same time intervals, but receive no active intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Reported postural changes, stiffness, discomfort and/or pain of musculoskeletal origin in the thoracic spine or chest wall.
  • Diagnosis of cystic fibrosis (confirmed by genotype or a sweat sodium concentration of >70mmol/l or sweat chloride of >60mmol/l)
  • Sixteen years of age or over
  • Patients in a stable clinical state with lung function at the time of entry that is within 10% of the mean of the last two recordings (separated by at least one month).
  • Forced Expiratory Volume in 1 second (FEV1) ≥30% predicted at time of entry to the study.

Exclusion Criteria:

  • Evidence of a current respiratory exacerbation (worsening) as defined by Thornton et al. 2004
  • Cor pulmonale (right heart failure)
  • Low bone density (Z score < -3)(WHO Study Group 1994)
  • Previous history of spontaneous fractures
  • Past history of spinal fracture or other known arthropathic (joint) or spinal disease process
  • Currently undergoing musculoskeletal (physiotherapy, chiropractic or osteopathic) treatment
  • Pregnancy
  • Inability to give consent
  • Current enrollment in another research trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716664

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Mrs Catherine Sandsund, Honorary Research Fellow in Physiotherapy,, Department of Cystic Fibrosis, Royal Brompton Hospital
ClinicalTrials.gov Identifier: NCT00716664     History of Changes
Other Study ID Numbers: 06/Q0404/81
Study First Received: July 15, 2008
Last Updated: March 10, 2009
Health Authority: Research Audit Office, UK:

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
cystic fibrosis
musculoskeletal
exercise capacity
 posture
lung function
physical functioning

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013