Cystic FibrosisNCT01729585
The Effects of Massage Therapy on QOL in Youth/Young Adults With Cystic Fibrosis
A study testing Massage Therapy in people with Cystic Fibrosis and Quality of Life, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Quality of Life
- What is being tested?
- Massage Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: The Effects of Massage Therapy on Quality of Life in Youth and Young Adults With Cystic Fibrosis: A Pilot Study
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).
Read the 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:
- 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:
- Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) scores,
- Single breath counting score, measuring ease of breathing, and
- 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
- Cystic Fibrosis, Quality of Life
- Being tested
- Massage Therapy
- Keywords
- cystic fibrosis, quality of life
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | control group |
| Massage therapy | Active comparator | Treatment group receives pre-determined massage therapy protocol x 5 over 10-12 weeks. massage therapy protocol includes a blend of Swedish strokes and myofascial trigger point therapy. Initially, dosing will be more frequent. Treatments will be spaced out to determine the ability of the body to maintain a more efficient musculoskeletal system, especially related to respiratory and postural efforts. Each session will end with resting hands and relaxation strokes to signal the end of the session. This protocol invites increased mobility in the musculoskeletal system. The ultimate goal is to return connective tissue (including muscles and fascia) to a more relaxed and neutral state, thus allowing expansion and ease of movement of the areas of the musculoskeletal system being worked. Receives: Procedure: Massage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life _Peds QOL and CFQ-R
standardized measures of quality of life will be administered to subject and to parents of subjects under 18 years of age. Muscle tightness, ease of breathing, and overall relaxation 0-10 scores captured subjective QOL data.
Measured: measured twice; visit 1 for baseline for treatment and control group and 10-12 weeks later following last treatment for treatment group, and same time frame for control group
Secondary outcomes (1)
Pulmonary function
Pulmonary function test will be obtained prior to first data collection visit, using clinical pft's for treatment and control groups. Clinical pft's will also be obtained for control group 10-12 weeks following first data set. For treatment group, research pft will be obtained following last massage 10-12 weeks following initial data collection.
Ease of breathing will be measured pre and post each massage for treatment group and at time 1 and 2 for control group.
Thoracic excursion will be measured pre and post each massage and x2 during each massage for treatment group, and at time 1 and 2 for control group.
Measured: pre treatment, prior to each massage, post treatment; Time 1 = initial data collection; collect data over 10-12 weeks for treatment group. For control group, time 1 is initial data collection; time 2 is 10-12 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJul 2013
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen A Zink, MSN, Principal investigator, Cincinnati Children's Hospital, Division of Child Life and Integrative Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729585
- Sponsor's protocol ID
- IRB#2009-0918
- Status last verified
- Sep 2015
- First submitted
- 15 Nov 2012
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zimmer, M., Bogenschutz, L., & Zink, K. (2008). Effect of massage therapy on pain in hospitalized pediatric cystic fibrosis patients. (abstract submitted to North American Research Conference on Complementary and Integrative Medicine, 2009).
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Massage Therapy on Quality of Life in Youth and Young Adults With Cystic Fibrosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT01729585
- Acronym / sponsor ID
- IRB#2009-0918
- Conditions
- Cystic Fibrosis, Quality of Life
- Keywords
- cystic fibrosis, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) scores,
- Single breath counting score, measuring ease of breathing, and
- Thoracic excursion as measured by the cloth tape measure technique? What changes in the above pulmonary function in each group are found over time?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –control group |
| Massage therapy | Active comparator | Procedure: Massage TherapyTreatment group receives pre-determined massage therapy protocol x 5 over 10-12 weeks. massage therapy protocol includes a blend of Swedish strokes and myofascial trigger point therapy. Initially, dosing will be more frequent. Treatments will be spaced out to determine the ability of the body to maintain a more efficient musculoskeletal system, especially related to respiratory and postural efforts. Each session will end with resting hands and relaxation strokes to signal the end of the session. This protocol invites increased mobility in the musculoskeletal system. The ultimate goal is to return connective tissue (including muscles and fascia) to a more relaxed and neutral state, thus allowing expansion and ease of movement of the areas of the musculoskeletal system being worked. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage TherapyThe 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. | Procedure or surgery | Massage therapy |
Primary outcome
Quality of life _Peds QOL and CFQ-R
Time frame: measured twice; visit 1 for baseline for treatment and control group and 10-12 weeks later following last treatment for treatment group, and same time frame for control group
standardized measures of quality of life will be administered to subject and to parents of subjects under 18 years of age. Muscle tightness, ease of breathing, and overall relaxation 0-10 scores captured subjective QOL data.
1 secondary outcome
Pulmonary function
Time frame: pre treatment, prior to each massage, post treatment; Time 1 = initial data collection; collect data over 10-12 weeks for treatment group. For control group, time 1 is initial data collection; time 2 is 10-12 weeks later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- BackgroundZimmer, M., Bogenschutz, L., & Zink, K. (2008). Effect of massage therapy on pain in hospitalized pediatric cystic fibrosis patients. (abstract submitted to North American Research Conference on Complementary and Integrative Medicine, 2009).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen A Zink, MSN principal investigator
Cincinnati Children's Hospital, Division of Child Life and Integrative Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Therapy in people with Cystic Fibrosis and Quality of Life, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life _Peds QOL and CFQ-R (time frame: measured twice; visit 1 for baseline for treatment and control group and 10-12 weeks later following last treatment for treatment group, and same time frame for control group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.