Do Musculoskeletal Techniques Improve Forced Expiratory Volume in One Second in Adults With Cystic Fibrosis?
Pilot Study: Do Physiotherapy Musculoskeletal Techniques Improve Forced Expiratory Volume in One Second in Adults With Cystic Fibrosis?
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 15, 2008
CompletedFirst Posted
Study publicly available on registry
July 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedMarch 11, 2009
July 1, 2008
1.4 years
July 15, 2008
March 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced expiratory volume in one second
12 weeks
Secondary Outcomes (8)
Forced vital capacity, peak expiratory flow rate
12 weeks
Visual analogue scale for pain
12 weeks
Modified shuttle test
12 weeks
The Cystic Fibrosis Quality of Life Questionnaire, section one: physical functioning
12 weeks
Flexi curve measurements of posture
12 weeks
- +3 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALThe experimental group receives the intervention in addition to normal optimal care
2
ACTIVE COMPARATORThe active comparator, or control group, receives normal optimal care only
Interventions
Undertaken by a physiotherapist, weekly, for six weeks
The control group are measured using the same outcome measures at the same time intervals, but receive no active intervention
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brompton Hospital
London, London, SW3 6NP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 15, 2008
First Posted
July 16, 2008
Study Start
March 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
March 11, 2009
Record last verified: 2008-07