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Investigating the obesity paradox in Chronic Obstructive Pulmonary Disease (COPD)

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000056897
Acronym
WLOP
Enrollment
33
Registered
2012-01-11
Start date
2011-09-12
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The effects of obesity in COPD are poorly understood, and this is an important area for future research. The mechanisms, consequences and optimal management approaches to this problem are largely unknown. Indeed, current clinical practice assumes that obesity is detrimental in COPD, with obese patients being encouraged to reduce their weight, via calorie reduction and restriction of energy dense foods. However, considering the evidence that obesity may be protective, it is important to understand the effect of weight reduction on inflammation, muscle mass and other significant clinical outcomes in obese COPD subjects. This important area of research is necessary for the development of nutritional guidelines, which currently do not exist in this area. The aim of this study is to determine the effect of weight reduction, involving dietary fat restriction, on inflammation, body composition, markers of COPD, metabolic and cardiovascular disease markers, quality of life and physical performance in obese COPD patients. We hypothesise that in COPD patients, weight reduction, involving dietary fat restriction coupled with resistance training will reduce inflammation, maintain muscle mass and improve clinical outcomes.

Interventions

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 o

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.

Sponsors

John Hunter Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026