The Effects of Massage Therapy on QOL in Youth/Young Adults With Cystic Fibrosis

Massage therapy (MT) is defined as hands on manipulation of the soft tissue of the body with
the intent to produce therapeutic, physiologic effects and to promote health and well-being
(Oawriter - OAC - codes.ohio.gov, 2010; American Massage Therapy Association, 2010). Quality
of life is defined as a self-description (child or adult) or parent's description of the
child's perceived health and well-being based on satisfaction with physical, emotional,
psychosocial and school/role functioning (Varni et al., 2002). Additional measures for this
study which may influence QOL include pain, pulmonary function, ease of breathing and
thoracic excursion.

Research Questions:

i. What differences in changes of QOL scores, as measured by the Peds QL 4.0 (Pediatric
Quality of Life Inventory) and the CFQ-R (Cystic Fibrosis Questionnaire - Revised) are found
in youth and young adults with CF between the group receiving MT and control group? What
changes in QOL scores in each group are found over time? ii. What differences in changes of
musculoskeletal pain, as measured by the Numeric Rating Scale for pain are found in youth
and young adults with CF between the group receiving MT and the control group? What changes
in pain scores in each group are found over time? iii. What differences in changes of the
pulmonary function are found in youth and young adults with CF between the group receiving
MT and the control group in terms of the following:

1. Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) scores,

2. Single breath counting score, measuring ease of breathing, and

3. Thoracic excursion as measured by the cloth tape measure technique? What changes in the
above pulmonary function in each group are found over time?

Inclusion Criteria:

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

Exclusion Criteria:

- 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