High Protein Diet and Physical Activity in COPD

The Effect of High Protein Diet in Combination With Physical Activity in the Rehabilitation of Patients With Chronic Obstructive Pulmonary Disease (COPD) at Risk of Malnutrition- a Pilot Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04888182

Enrollment

Registered

2021-05-17

Start date

2018-03-01

Completion date

2019-10-01

Last updated

2021-05-21

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

Conditions

COPD

Brief summary

COPD outpatients with severe and very severe (grade III-IV) disease at risk of malnutrition commencing rehabilitation (7-10-week physical activity program) were randomized to receive a high protein diet (≥ 25 energy percentage) or standard care.

Detailed description

Peripheral muscle function was measured by 6MWD (6-meter-walk-distance) and handgrip strength; FFM was measured by bioimpedance, mid upper arm circumference, and mid-thigh circumference; quality of life was measured by CAT (????); and dyspnoea was measured by the Medical Research Council dyspnoea scale and Borg scores at baseline and after 12 weeks.

Interventions

DIETARY_SUPPLEMENTintervention

a protein intake of ≥25 E%. An oral nutritional supplement (containing 1570 kJ/100 g and 92 g protein/100 g. Atpro 200) was used as supplement to the patients' habitual diet.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized, parellel, not blinded

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

* diagnosed COPD stage III or stage IV * Nutritional risk by screening (NRS-2002)(Kondrup et al, 2002) and/or low-fat free mass (FFMI) (≤ 15% for women and ≤ 16% for men) measured by Bioelectrical Impedance Analysis (BIA)

Exclusion criteria

* Terminal phase of COPD * Lung transplanted patients * Severe Comorbidities influenzing the end-points (pancreatic insufficiency, severe hepatic failure, inflammatory gastrointestinal disease) * Multiple sclerosis * Any unwillingness or inability (e.g. not able to make notes of their nutritional intake, come to consultations or manage oral intake)

Design outcomes

Primary

Measure	Time frame	Description
6-minute walk test (6MWD)	7 weeks	metres
hand grip strenght	7 weeks	kg

Secondary

Measure	Time frame	Description
Fat Free Mass (FFM)	7 weeks	Bioimpedance - kg
Dyspnoea after 6 minutes walk	7 weks	Medical Research Council (MRC) dyspnoea scale (scores range from 0 to 5)
Quality of life	7 weeks	self-administered COPD Assessment Test (CAT), 40-point scale

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026