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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716664
First Posted: July 16, 2008
Last Update Posted: March 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


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 ]

Secondary Outcome Measures:
  • Forced vital capacity, peak expiratory flow rate [ Time Frame: 12 weeks ]
  • Visual analogue scale for pain [ Time Frame: 12 weeks ]
  • Modified shuttle test [ Time Frame: 12 weeks ]
  • The Cystic Fibrosis Quality of Life Questionnaire, section one: physical functioning [ Time Frame: 12 weeks ]
  • Flexi curve measurements of posture [ Time Frame: 12 weeks ]
  • Chest wall excursion measurements [ Time Frame: 12 weeks ]
  • 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 ]
  • Questionnaire II - the subject's perspective [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716664


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

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
First Submitted: July 15, 2008
First Posted: July 16, 2008
Last Update Posted: March 11, 2009
Last Verified: July 2008

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

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