The Effects of Massage Therapy on QOL in Youth/Young Adults With Cystic Fibrosis
Completed · Not applicable
Conditions studied: Cystic Fibrosis, Quality of Life
In brief
The purpose of this study is to describe the effects of massage therapy on quality of life (QOL) in youth and young adults (ages 8 to 21 years) with cystic fibrosis (CF).
Key facts
- Study ID
- NCT01729585
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 30
- Starts
- 2013-07-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-09-28
Who can join
Age: 8 and older, up to 21. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Inclusion Criteria:
- Diagnosis of CF evidenced by a prior documented positive sweat test (>60 mEq/ml by quantitative pilocarpine iontophoresis and genotype with two identified mutations consistent with CF)
- Males and females, aged 8 to 21 years at time of enrollment to obtain a broad range of symptoms related to tissue changes. (Over time, individuals with CF present with increasing symptoms with age and disease progression.)
- English speaking
- Pulmonary function clinical baseline <100% (Baseline is defined as the highest PFT during the 6 months prior to PFT at enrollment.) * This criteria was eliminated to expand eligible subjects (including PFT baseline >100).
- Clinically stable as defined by no evidence of acute upper or lower respiratory tract infections or other acute illnesses requiring use of antibiotics for at least 14 days prior to enrollment. (Pulmonary exacerbation often includes cough which may affect responses to MT.) * this criteria was omitted after study began as subjects were frequently being treated with antibiotics secondary to CF and pulmonary exacerbations.
- Approval to participate from Pulmonary Physician
- Informed consent to participate
You may not qualify if…
- Exposed to any investigational drug or device within 30 days of enrollment
- Any other illness at time of enrollment not a direct result of CF that the pulmonary physician determines that MT is contraindicated
- Inability to lay flat on massage table as is required for massage protocol
- Platelet count within past 12 months < 100,000. (Contraindication for deep tissue MT.) *eliminated this criteria with medical approval.
- INR International Normalized Ratio (INR) - (blood test used to monitor the effectiveness of blood thinning drugs) within past 12 months > 1.5 (Delayed clotting time is a contraindication for deep tissue MT.) * eliminated this criteria with medical approval.
- History of hepatosplenomegaly as deep tissue massage is contraindicated.
- History of lung and/or liver transplant as deep tissue MT may be contraindicated with anti-rejection drug protocol.
- Received MT within the past 30 days to eliminate the potential bias of previous response to treatment. *changed protocol to allow enrollment and wait 30 days to initiate protocol.
- Skin condition or injury that would be contraindicated for MT and would restrict ability to apply massage strokes according to protocol
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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