Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001031752
Ethics application status
Approved
Date submitted
12/09/2013
Date registered
16/09/2013
Date last updated
18/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise and Nutrition Intervention for Patients with Psoriasis
Scientific title
The effect of an exercise and nutrition intervention on body composition in patients with psoriasis
Secondary ID [1] 283213 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 290076 0
Condition category
Condition code
Skin 290458 290458 0 0
Dermatological conditions
Inflammatory and Immune System 290471 290471 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediate Exercise Group:
The physical exercise intervention program will include 12 weeks of resistance (i.e. lifting weights) and aerobic exercise (e.g. walking, jogging, cycling) undertaken 3 times per week in an exercise clinic. Exercise sessions will take approximately 60 minutes and will be conducted in small groups under the supervision of an accredited exercise physiologist. Participants will also receive 3 one-on-one 45 minute consultations with a dietician during weeks 1, 2 and 3 of the intervention. These consultations will involve advice about nutritional intake for healthy fat loss, maximising gains in muscle as well as reducing whole body inflammatory state. Attendance rates and exercise training logs will be used to monitor adherence with the intervention.
Intervention code [1] 287939 0
Lifestyle
Comparator / control treatment
Delayed Exercise Group: Participants will maintain their normal lifestyle for 12 weeks and then will receive the exercise intervention and consultations with a dietician for the following 12 weeks (i.e. 12-24 weeks).
Control group
Active

Outcomes
Primary outcome [1] 290484 0
Whole body and regional fat and lean mass as determined by Dual Energy X-Ray Absorptiometry
Timepoint [1] 290484 0
Baseline (0 weeks), post-intervention (12 weeks) and follow-up (24 weeks)
Secondary outcome [1] 304600 0
Muscle density and muscle cross-sectional areas of the lower limb as determined by Peripheral Quantitative Computed Tomography
Timepoint [1] 304600 0
Baseline (0 weeks), post-intervention (12 weeks) and follow-up (24 weeks)
Secondary outcome [2] 304601 0
Physical function - muscle strength as determine by one repetition maximum in the leg press, chest press and seated row and cardiorespiratory fitness as determined by a sub-maximal treadmill test.
Timepoint [2] 304601 0
Baseline (0 weeks), post-intervention (12 weeks) and follow-up (24 weeks)
Secondary outcome [3] 304602 0
Resting metabolic rate will be determined using expired air analysis.
Timepoint [3] 304602 0
Baseline (0 weeks), post-intervention (12 weeks) and follow-up (24 weeks)
Secondary outcome [4] 304603 0
Insulin, glucose, triglycerides, cholesterol, IGF-1, leptin, CRP, TNF Alpha and IL-6 will be measured from a blood sample
Timepoint [4] 304603 0
Baseline (0 weeks), post-intervention (12 weeks) and follow-up (24 weeks)
Secondary outcome [5] 304604 0
The Medical Outcomes Study 36-Item Short-Form Health Survey and the Dermatology Life Quality Index will be used to assess quality of life.
Timepoint [5] 304604 0
Baseline (0 weeks), post-intervention (12 weeks) and follow-up (24 weeks)
Secondary outcome [6] 304639 0
The Psoriatic Arthritis Screening and Evaluation Questionnaire as well as the WOMAC Osteoarthritis Index will be used to assess psoriasis severity.
Timepoint [6] 304639 0
Baseline (0 weeks), post-intervention (12 weeks) and follow-up (24 weeks)
Secondary outcome [7] 304640 0
The Godin Leisure-Time Exercise Questionnaire will be used to assess physical activity level.
Timepoint [7] 304640 0
Baseline (0 weeks), post-intervention (12 weeks) and follow-up (24 weeks)
Secondary outcome [8] 304641 0
A 3-day food diary will be used to assess dietary intake.
Timepoint [8] 304641 0
Baseline (0 weeks), post-intervention (12 weeks) and follow-up (24 weeks)

Eligibility
Key inclusion criteria
Currently receiving Humira for management of psoriasis
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any neurological, musculoskeletal or cardio respiratory condition which would put potential participants at risk during exercise or inhibit their ability to adapt to an exercise program.

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)
Central randomisation by computer. Written informed consent will be required prior to any testing or randomisation. subjects who dropout prior to completing baseline testing will not be randomised
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by a randomisation table created by a computer sequence. Randomisation is at the level of the individual patient and will be stratified by age and sex.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The two groups of participants receive different interventions during the same time span of the study, however the delayed exercise group receive the intervention after 12 weeks of usual care.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/09/2013
Actual
10/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287958 0
Commercial sector/Industry
Name [1] 287958 0
Abbvie Australasia Pty Ltd
Country [1] 287958 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 286679 0
Individual
Name [1] 286679 0
Professor Robert Newton
Address [1] 286679 0
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country [1] 286679 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Psoriasis is a chronic and lifelong autoimmune disease which affects the skin and for one in four sufferers also results in arthritis. Tumour necrosis factor (TNF) is believed to play a role in psoriasis by acting as a regulator of inflammation. Exercise, fat loss and muscle gain have been proven to reduce chronic inflammatory state in the body as well as lower TNF levels. Exercise and dietary modification may enhance the effectiveness of pharmaceutical therapies such as Humira, a TNF blocker which has been very effective for the management of psoriasis and other autoimmune diseases. Our main aim is to find out if an exercise and nutritional support program can reduce body fat, improve physical fitness and function, lower inflammatory status, and improve the cardiometabolic risk profile of patients receiving Humira for psoriasis.
Trial website
www.ecuhealthwellnessinstitute.org/research-activity/projects
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42938 0
Prof Robert Newton
Address 42938 0
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 42938 0
Australia
Phone 42938 0
+61 8 6304 5037
Fax 42938 0
Email 42938 0
[email protected]
Contact person for public queries
Name 42939 0
Prof Robert Newton
Address 42939 0
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 42939 0
Australia
Phone 42939 0
+61 8 6304 5037
Fax 42939 0
Email 42939 0
[email protected]
Contact person for scientific queries
Name 42940 0
Prof Robert Newton
Address 42940 0
Edith Cowan University
270 Joondalup Drive
Joondalup, WA 6027
Country 42940 0
Australia
Phone 42940 0
+61 8 6304 5037
Fax 42940 0
Email 42940 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
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