Trials / Completed
CompletedNCT01729585
The Effects of Massage Therapy on QOL in Youth/Young Adults With Cystic Fibrosis
The Effects of Massage Therapy on Quality of Life in Youth and Young Adults With Cystic Fibrosis: A Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 8 Years – 21 Years
- Healthy volunteers
- Accepted
Summary
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).
Detailed description
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?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Massage Therapy | The Massage Therapy protocol consists of a series of 5 massages administered over 10 (+2) weeks. Length of time for each visit will be approximately 1.5 - 2 hours Typically, a series of treatments over time allows the body time to integrate tissue related changes and potentially maintain a more healthy musculoskeletal state. Based on expert opinion in the field of MT, following a series of massage treatments administered over time, one can anticipate tissue changes. By adding time between treatments, data will describe the ability of subjects to maintain changes over progressively longer periods of time. Treatment protocol will be based on the application of myofascial trigger point therapy (Timberlake, 1999) to musculoskeletal areas of the body often affected by disease progression in CF. |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2015-01-01
- Completion
- 2015-03-01
- First posted
- 2012-11-20
- Last updated
- 2015-09-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01729585. Inclusion in this directory is not an endorsement.