Do Musculoskeletal Techniques Improve Forced Expiratory Volume in One Second in Adults With Cystic Fibrosis? - Full Text View

Sponsored by:	Royal Brompton Hospital NHS Trust
Information provided by:	Royal Brompton Hospital NHS Trust
ClinicalTrials.gov Identifier:	NCT00716664

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

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Pilot Study: Do Physiotherapy Musculoskeletal Techniques Improve Forced Expiratory Volume in One Second in Adults With Cystic Fibrosis?

Further study details as provided by Royal Brompton Hospital NHS 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
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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 arthopathic (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	Completed
London, United Kingdom, SW3 6NP
Royal Brompton Hospital	Recruiting
London, United Kingdom, SW3 6NP
Contact: Catherine A Sandsund, MSc c.sandsund@rbht.nhs.uk
Contact: Jennifer A Pryor, pHD j.pryor@rbht.nhs.uk
Principal Investigator: Catherine A Sandsund, MSc

Sponsors and Collaborators

Royal Brompton Hospital NHS Trust

More Information

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

Keywords provided by Royal Brompton Hospital NHS Trust:

cystic fibrosis
musculoskeletal
exercise capacity

posture
lung function
physical functioning

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009