Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000056897
Ethics application status
Approved
Date submitted
11/01/2012
Date registered
11/01/2012
Date last updated
17/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the obesity paradox in Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
Weight loss with a diet and exercise intervention for obese people with Chronic Obstructive Pulmonary Disease (COPD) and its impact on high sensitivity C-reactive protein.
Secondary ID [1] 279697 0
Nil
Universal Trial Number (UTN)
Trial acronym
WLOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 285526 0
Obesity 285542 0
Condition category
Condition code
Respiratory 285720 285720 0 0
Chronic obstructive pulmonary disease
Diet and Nutrition 285733 285733 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the intervention participants will consume a low calorie diet for 3 months (3350-5000 kJ/day based on baseline BMI). Meal replacements (nutritionally complete if 3/day consumed) will be provided and consumed by participants for two meals per day. Each meal replacement will contain approx 870kJ/serve; approximately 50% carbohydrate, 40% protein and 10% fat. Participants will be educated to consume a third meal and two snacks that ensure adequate nutrients. Snacks will include fruit, nuts or snack bars. Intake will include at least 20g of fat /day, psyllium husks and a small amount of caffeine in the form of coffee, tea or diet soft drink; these are to reduce risk of gall stone development. Protein intake will be 1.2-1.5g/kg body weight /day to minimise muscle loss. Face-to-face counselling with a dietitian will occur at baseline, then fortnightly for the duration of the study for a duration of 2 hours at baseline and 1 hour for fortnightly visits thereafter. During the weeks that participants are not scheduled for face-to-face counselling, they will by counselled via telephone for a duration of 10 minutes. Adherence will be monitored using food diaries, which will be reviewed by a dietitian throughout the study, and body weight and waist circumference will be assessed at each visit. We expect participants to lose 10% body weight within 3 months.

The dietary intervention will be coupled with an exercise programme of resistance training for a duration of 12 weeks. Participants will be asked to perform a home based upper and lower limb strength training programme 3 days per week with a rest day in between training sessions. An experienced physiotherapist trained in exercise prescription will recommend the training programme. The specific exercises will include bicep curls, shoulder presses in a sitting or standing position, wall push ups, squats, step ups, lunges, a seated row exercise and sit to stand exercises. These exercises are recommended for strength training by The Australian Lung Foundation. Participants will receive instruction in the exercises and precautions for training. Any contraindications for exercise will be assessed and considered in the prescription of the exercise programme. Load will be prescribed according to the participant’s 10-12 Repetition Maximum, equivalent to the highest weight the participant is able to lift through the full range of motion of the specified exercise 10-12 times, providing there is no pain or significant dyspnoea reported. The exercise program will be reassessed by a physiotherapist on a fortnightly basis directly following the dietary consultation, for a duration of 45 minutes. Progression of load will be advised based on the reassessed 10-12 repetition maximum weight achieved. The load will only be upgraded under supervision. The participants will complete 3 sets of 10-12 repetitions.

Adherence to and monitoring of the exercise programme will be assessed at each face to face counselling visit which will occur fortnightly. On the weeks that a face to face visit is not occurring, a phone call will be made to the participant to encourage adherence and discuss any issues that may arise.
Intervention code [1] 283988 0
Treatment: Other
Intervention code [2] 284004 0
Behaviour
Intervention code [3] 284005 0
Lifestyle
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286240 0
High sensitivity C-reactive protein measured by ELISA
Timepoint [1] 286240 0
0 and 12 weeks
Secondary outcome [1] 295433 0
Body composition measured by bioimpedance analysis.
Timepoint [1] 295433 0
0, 2, 4, 6, 8, 10, 12 weeks.
Secondary outcome [2] 295434 0
Weight by bioimpedance analysis and digital weighing scales.
Timepoint [2] 295434 0
0, 2, 4, 6, 8, 10, 12 weeks.
Secondary outcome [3] 295435 0
Body Mass Index (BMI)
Timepoint [3] 295435 0
0 and 12 weeks
Secondary outcome [4] 295436 0
Waist circumference
Timepoint [4] 295436 0
0, 2, 4, 6, 8, 10, 12 weeks.
Secondary outcome [5] 295437 0
Muscle Mass measured by Dual Energy X-ray Absorbtiometry (DEXA)
Timepoint [5] 295437 0
0 and 12 weeks
Secondary outcome [6] 295438 0
A blood sample will be obtained using venepuncture and systemic inflammatory markers (plasma IL-6, Leptin)will be measured by ELISA.
Timepoint [6] 295438 0
0 and 12 weeks
Secondary outcome [7] 295439 0
A sputum sample will be obtained by sputum induction using hypertonic saline. Airway inflammation will be assessed from sputum cell counts.
Timepoint [7] 295439 0
0 and 12 weeks
Secondary outcome [8] 295440 0
Airflow obstruction will be assessed in each participant using spirometry (KoKo K313100 PDS Instrumentation, Louisville, CO, USA) to measure pre and post bronchodilator FEV1, FVC and FEV1/FVC%.
Timepoint [8] 295440 0
0 and 12 weeks
Secondary outcome [9] 295441 0
Exercise capacity will be assessed using the 6 minute walk test and short physical performance battery.
Timepoint [9] 295441 0
0 and 12 weeks
Secondary outcome [10] 295463 0
Quality of life will be assessed using the St George Respiratory Questionnaire
Timepoint [10] 295463 0
0 and 12 weeks.
Secondary outcome [11] 295464 0
Blood pressure and arterial stiffness (pulse wave velocity and augmentation index) will be assessed using applanation tonometry (Sphygmacor).
Timepoint [11] 295464 0
0 and 12 weeks.
Secondary outcome [12] 295465 0
A blood sample will be obtained using venepuncture and metabolic markers (Blood glucose, triglycerides, LDL/HDL) will be analyzed by Hunter Area Pathology Service, John Hunter Hospital.
Timepoint [12] 295465 0
0 and 12 weeks.

Eligibility
Key inclusion criteria
*Diagnosed COPD defined by a post bronchodilator FEV1 < 80% predicted and FER < 0.70
*Obesity defined by a BMI > 30kg/m2
*Satisfactory written and verbal English language skills.
*Willing and able to attend study visits
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Significant co-morbidity that the study visits may impact on
*Current smoker (smoked within the past 6 months);
*Pregnancy or breastfeeding;
*Taking insulin;
*A medical condition requiring a specialised dietary plan
*Cardiac arrhythmia, angina, congestive heart failure
*Renal or hepatic failure;
*Current gallstones
*Pancreatitis;
*Oedema
*Systemic disease (such as cancer);
*Change in medications or weight (+/- 5% body weight) in the previous 3 months; and
*Orthopaedic problems that would compromise the capacity to perform exercise.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed as there is no control group.

Participant recruitment will be via the respiratory ambulatory care clinics at JHH.

Participants will be invited to attend a study visit to collect baseline outcome data. They will then enter the intervention phase of the study for 3 months. At the end of this period they will attend a further assessment to collect follow up study outcomes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284479 0
Hospital
Name [1] 284479 0
John Hunter Hospital
Country [1] 284479 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Locked Bag 1 HRMC
NSW 2310
Country
Australia
Secondary sponsor category [1] 283404 0
University
Name [1] 283404 0
The University of Newcastle
Address [1] 283404 0
University Drive
Callaghan, NSW 2308
Country [1] 283404 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286459 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 286459 0
Ethics committee country [1] 286459 0
Australia
Date submitted for ethics approval [1] 286459 0
Approval date [1] 286459 0
21/06/2011
Ethics approval number [1] 286459 0
11/06/15/4.03

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33608 0
Address 33608 0
Country 33608 0
Phone 33608 0
Fax 33608 0
Email 33608 0
Contact person for public queries
Name 16855 0
Penny Baines
Address 16855 0
Hunter Medical Research Insitute
Level 2 John Hunter Hospital
Lookout Road
New Lambton, NSW 2305
Country 16855 0
Australia
Phone 16855 0
+61249214108
Fax 16855 0
+61249855850
Email 16855 0
[email protected]
Contact person for scientific queries
Name 7783 0
Dr Vanessa McDonald
Address 7783 0
Department of Respiratory and Sleep Medicine
John Hunter Hospital
Lookout Road
New Lambton, NSW 2305
Country 7783 0
Australia
Phone 7783 0
+61249213470
Fax 7783 0
+61249855850
Email 7783 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.