High Protein Diet and Physical Activity in COPD

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888182
• Other study ID #: BBH-KU 33
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: May 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• COPD

Intervention

Dietary Supplement:
• intervention
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.

Locations

Country	Name	City	State
Denmark	Department of Pulmonary Medicine	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Jens Rikardt Andersen	Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk test (6MWD)	metres	7 weeks
Primary	hand grip strenght	kg	7 weeks
Secondary	Fat Free Mass (FFM)	Bioimpedance - kg	7 weeks
Secondary	Dyspnoea after 6 minutes walk	Medical Research Council (MRC) dyspnoea scale (scores range from 0 to 5)	7 weks
Secondary	Quality of life	self-administered COPD Assessment Test (CAT), 40-point scale	7 weeks