High Protein Diet and Physical Activity in COPD

Sponsor

Jens Rikardt Andersen (Other)

Overall Status

Completed

CT.gov ID

NCT04888182

Collaborator

Bispebjerg Hospital (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Dietary Supplement: intervention	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, parellel, not blindedRandomized, parellel, not blinded

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intervention Individual nutritional guidance of a protein intake of ≥25 E%.	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.
No Intervention: control Free diet

Arm

Intervention/Treatment

Active Comparator: intervention

Individual nutritional guidance of a protein intake of ≥25 E%.

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.

No Intervention: control

Free diet

Outcome Measures

Primary Outcome Measures

6-minute walk test (6MWD) [7 weeks]
metres
hand grip strenght [7 weeks]
kg

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pulmonary Medicine	Copenhagen		Denmark	2400

Sponsors and Collaborators

Jens Rikardt Andersen
Bispebjerg Hospital

Investigators

Principal Investigator: Jens R Andersen, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jens Rikardt Andersen, Associate Professor, Primary Investigator, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT04888182

Other Study ID Numbers:

BBH-KU 33

First Posted:

May 17, 2021

Last Update Posted:

May 21, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 21, 2021