Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000484347
Ethics application status
Approved
Date submitted
20/08/2008
Date registered
29/09/2008
Date last updated
29/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stretching in Cystic Fibrosis: Does it improve quality of life?
Scientific title
Stretching in Cystic Fibrosis: Does it improve quality of life and measures of lung function.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory and musculoskeletal problems in cystic fibrosis 3590 0
Condition category
Condition code
Respiratory 3750 3750 0 0
Other respiratory disorders / diseases
Musculoskeletal 3751 3751 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 3808 3808 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment group will undertake stretches of the pectoralis muscles, latissimus dorsi and lower trapezius muscles. A static stretch will be held for 30 seconds and then repeated twice. They will also complete thoracic extension and thoracic rotation exercises using the back of a chair, each stretch held for 30 seconds and repeated twice. The stretches will be taught to the patients by a physiotherapist and then performed independantly daily for 6 weeks.
Intervention code [1] 3304 0
Treatment: Other
Comparator / control treatment
The control group will undertake quadriceps, calf, adductor and hamstring stretches. Each stretch will be held for 30 seconds and then repeated twice. These will be taught to the patient by a physiotherapist and then performed in dependantly daily for six weeks.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4648 0
Airway function (change in vital capacity (VC)) as measured by the Easy One screen spirometer.
Timepoint [1] 4648 0
Baseline and 6 weeks
Primary outcome [2] 4707 0
Airway function (change in Forced Expiratory Volume in 1 second (FEV1)) as measured by the Easy One screen spirometer.
Timepoint [2] 4707 0
Baseline and 6 weeks
Secondary outcome [1] 7857 0
Subjective ease of breathing as measured on a 10cm visual analogue scale.
Timepoint [1] 7857 0
Baseline and 6 weeks
Secondary outcome [2] 7942 0
Pain and disability as scored using the Pain dysfunction questionnaire (Anagnostics et al. 2004)
Timepoint [2] 7942 0
Baseline and 6 weeks
Secondary outcome [3] 8004 0
Quality of life measures using the Cystic Fibrosis Questionnaire - revised (CFQ-R) Teen/Adult (Quittner et al., 2000)
Timepoint [3] 8004 0
Baseline and 6 weeks
Secondary outcome [4] 8005 0
Change in measurements of Thoracic kyphosis using the Thoracic Index of Kyphosis Calculation (TI)
(Hinman et al., 2004)
Timepoint [4] 8005 0
Baseline and 6 weeks
Secondary outcome [5] 8006 0
Changes in chest wall excursion using the Chest Wall excursion measurement (CWE) (Custers et al., 2005)
Timepoint [5] 8006 0
Baseline and 6 weeks
Secondary outcome [6] 8007 0
Changes in Shoulder range of movement measurements using a Goniometer
Timepoint [6] 8007 0
Baseline and 6 weeks

Eligibility
Key inclusion criteria
Inclusion criteria

1. diagnosed with Cystic Fibrosis
2. 18 years
3. FEV1 = 40% predicted or above
4. clinically stable
5. lung function > 90% of the mean outpatient FEV1 recording over the last 6 months
6. > 2 weeks post completion of last antibiotics for a pulmonary infection
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Below 40% FEV1 predicted
2. loss of clinical stability of their condition
3. long-term high dose prednisone
4. changes in activities, exercise programme or physiotherapy treatment within the past week
5. shoulder dysfunction
6. recent fractures or injury to the ribs, clavicle or upper limb
7. recurrent subluxation or dislocation or dislocation of either shoulder
8. inability to form isometric contraction
9.connective tissue disorders (eg Ehlos Danlos syndrome)
10. ischaemic heart disease
11. uncontrolled hypertension
12. systemic disease affecting muscles and joints eg Rheumatoid arthritis and CF related arthritis
13. recent chest or abdominal surgery
14. pregnancy
15. acute musculoskeletal pain requiring active physiotherapy/musculoskeletal treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be randomly allocated to a treatment or sham (control) group using a simple procedure of sequential choice from a set of preshuffled sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using procedures such as coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3765 0
Hospital
Name [1] 3765 0
The Prince Charles Hospital
Country [1] 3765 0
Australia
Primary sponsor type
Government body
Name
Health Practitioner Research Scheme
Address
Health Practitioner Research Scheme
Director
Allied Health Workforce Advice and Coordination Unit (AHWACU)
6th Floor, Queensland Health Building
147-163 Charlotte St.
GPO Box 48
Brisbane QLD 4001
Country
Australia
Secondary sponsor category [1] 3377 0
None
Name [1] 3377 0
Address [1] 3377 0
Country [1] 3377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5824 0
Human Research Ethics Committee
Ethics committee address [1] 5824 0
The Prince Charles Hospital
Northern Health Dsitrict
Rode Rd
Chermside QLd 4032
Ethics committee country [1] 5824 0
Australia
Date submitted for ethics approval [1] 5824 0
Approval date [1] 5824 0
17/07/2008
Ethics approval number [1] 5824 0
EC27108

Summary
Brief summary
Cystic Fibrosis (CF) is a commonly inherited genetic disorder affecting numerous bodily systems, with great impact on the respiratory system including thoracic muscles. Although musculoskeletal problems such as back pain appear to be common in CF patients, there has been little research conducted to investigate the efficacy of musculoskeletal techniques such as stretching in this population.

Cystic fibrosis patients are invited to take part in a study to investigate the effects of stretching exercises on quality of life.

Background
You will be invited to attend one session, lasting 60 minutes at the Department of Physiotherapy, Prince Charles Hospital, where a physiotherapist will assess the following:
1.How much air you can breathe out in 1 second, repeated up to 6 times
2.Amount of movement you have in your arms, using a device to measure angles
3.How much you move your upper, middle and lower chest during breathing, by placing a tape measure around your chest and asking you to breathe in and out 3 times.
4.Measuring the curve of your thoracic spine by placing a soft mouldable ruler over your spine while standing
5.Fill out a questionnaire containing questions regarding your quality of life.
6.Fill out a questionnaire containing questions how your pain affects your daily tasks

After the 1st session, you will be randomly allocated to one of the following groups.

Arm stretches group: This involves completing a series of stretches for your arms and trunk over the 6 week period. Your physiotherapist will show you these exercises. You will be asked to do these once a day over the study period and complete a diary of how many exercises you performed each day.

Leg stretches group: This involves completing a series of stretches for your legs over the 6 week period. Your physiotherapist will show you these exercises. You will be asked to do these once a day over the study period and complete a diary of how many exercises you performed each day.

At the end of the 6 week period, you will be asked to attend another visit to repeat the above measures.

Benefits
Your participation in the study is not likely to benefit you directly but may assist in the development of future rehabilitation programs for patients with cystic fibrosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28867 0
Address 28867 0
Country 28867 0
Phone 28867 0
Fax 28867 0
Email 28867 0
Contact person for public queries
Name 12024 0
Michelle Wood
Address 12024 0
Physiotherapy Depatment
The Prince Charles Hospital
Rode Rd
Chermside QLD 4032
Country 12024 0
Australia
Phone 12024 0
07 3139 4000
Fax 12024 0
Email 12024 0
[email protected]
Contact person for scientific queries
Name 2952 0
Kathleen Hall
Address 2952 0
Physiotherapy Depatment
The Prince Charles Hospital
Rode Rd
Chermside QLD 4032
Country 2952 0
Australia
Phone 2952 0
07 3139 4000
Fax 2952 0
Email 2952 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.