Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001354178
Ethics application status
Approved
Date submitted
7/09/2019
Date registered
3/10/2019
Date last updated
3/03/2021
Date data sharing statement initially provided
3/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
How nutrition supplements may improve exercise capacity in people with Chronic Obstructive Pulmonary Disease attending outpatient pulmonary rehabilitation program.
Scientific title
The effect of nutritional supplementation on exercise capacity in people with Chronic Obstructive Pulmonary Disease attending pulmonary rehabilitation. A non-randomised intervention pilot study.
Secondary ID [1] 299127 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease
314195 0
Condition category
Condition code
Respiratory 312551 312551 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in intervention group:
Participants who agree to consume a nutritional supplement will be provided with the nutritional supplement Fortisip compact protein for the duration of their program. Fortisip compact protein is a ready-to-drink, high energy, high protein, vitamin and mineral rich oral nutritional supplement containing 300 kcal and 18 g protein per 125 ml bottle. Fortisip compact protein is a liquid formulation produced by Nutricia Advanced Medical Nutrition and is a common nutritional supplement recommended and provided in some NSW hospitals as well as outpatient and community health settings as a standard process for nutrition intervention.
Participants of this study will be required to consume one 125ml Fortisip compact protein daily orally for the duration of the program (16 sessions/8weeks). Participants will be encouraged to consume the nutritional supplement at time of physical activity however compliance of this will not be monitored.
To monitor adherence, participants will be provided with a compliance log sheet and they will be requested to sign off daily once they have consumed their nutritional supplement. Participants will be requested to bring their compliance log sheet in weekly at their scheduled exercise session.

Participants in non- randomised control group:
Intervention and control participants will need to attend twice weekly pulmonary rehabilitation group exercise sessions for eight weeks facilitated by the physiotherapists. Each exercise session runs for 1.5hours. Participant’s level of intensity whilst completing exercise session is monitored using the Borg Scale of Perceived Exertion. Intensity is moderate, set at Borg/ RPE of 3-4. The exercise session includes: a walking track, stationary cycling, treadmill, upper limb exercises with dumbbells and therabands, lower limb exercises mostly using the patient’s body weight (e.g: sit-to-stand, stepping, lunges).

Participants also complete one half hour nutrition group education session facilitated by a dietitian. As this is a ‘rolling’ program the nutrition session occurs at different stages of the 8 week program for each participant.
Participants will be attending outpatient pulmonary rehabilitation program running at Royal North Shore Community Health Centre, Mona Vale Community Health Centre, Brookvale Community Health Centre, Ryde Hospital or Hornsby Ku-ring-gai Hospital.

All participants will have the following measurements taken:
Baseline measurements:
Completed by physiotherapist:
• 6MWT
• Body weight, BMI
• 5STS
• St George’s respiratory questionnaire
Completed by dietitian
• Hand grip strength
• MNA
Discharge measurements:
Completed by physiotherapist:
• 6MWT
• 5STS
• St George’s respiratory questionnaire
Completed by dietitian
• Body weight, BMI
• Hand grip strength
• MNA
Intervention code [1] 315404 0
Treatment: Other
Comparator / control treatment
Participants that do not wish to consume the oral nutrition supplement but are willing to have baseline and discharge measurements taken, will be assigned to the control group.
They will have the following measures taken:
Baseline measurements:
Completed by physiotherapist:
• 6MWT
• Body weight, BMI
• 5STS test
• St George’s respiratory questionnaire
Completed by dietitian
• Hand grip strength
• MNA
Discharge measurements:
• 6MWT
• 5STS
• St George’s respiratory questionnaire
Completed by dietitian
• Body weight, BMI
• Hand grip strength
• MNA

They will receive standard care which is two 1.5 hour exercise sessions each week for 8 weeks (16 sessions) and attendance at one half hour nutrition education session.
Control group
Active

Outcomes
Primary outcome [1] 321201 0
Exercise capacity will be measured by the six minute walk test (6MWT) where distance walked in six minutes will be measured.
Timepoint [1] 321201 0
6MWT will be assessed at intitial assessment (prior to commencement of 8 week program). This will then be repeated at the end of the 8 week (16 session) program at their discharge assessment.
Secondary outcome [1] 374304 0
Changes in anthropometric measurements including body weight and body mass index (BMI) measured using calibrated digital scales located at each site and mathematical calculation of BMI. Height is measured using a stadiometer.
Timepoint [1] 374304 0
Body weight will be taken and BMI calculated at baseline and at discharge (completion of 16 sessions).
Secondary outcome [2] 374305 0
Assessment of nutritional status will be measured using the Mini Nutritional Assessment (MNA).
Timepoint [2] 374305 0
The MNA will be completed at baseline and repeated on discharge (completion of 16 sessions).
Secondary outcome [3] 374306 0
Changes in Health-Related Quality of Life (HRQoL) will be measured using the St George’s Respiratory Questionnaire.
Timepoint [3] 374306 0
The St George’s Respiratory Questionnaire will be completed at initial assessment and on discharge (completion of 16 sessions).
Secondary outcome [4] 374307 0
Quadriceps capacity will be assessed using the five-repetition sit-to-stand test (5STS).

Timepoint [4] 374307 0
The five-repetition sit-to-stand test (5STS) will be completed at initial assessment and on discharge (completion of 16 sessions).
Secondary outcome [5] 374308 0
Hand grip strength (measuring arm and upper body strength) will be measured with the use of a dynamometer.
Timepoint [5] 374308 0
hand grip strength will be taken at baseline and discharge (completion of 16 sessions). .

Eligibility
Key inclusion criteria
• Clinical diagnosis of COPD (FEV1/FVC <0.70)
• Completion of pulmonary rehabilitation initial assessment including two 6MWTs
• Willingness to give written informed consent and willingness to comply with the study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• BMI >30kg/m2
• Milk allergy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14724 0
Mona Vale Hospital - Mona Vale
Recruitment hospital [2] 14725 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [3] 14726 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 14727 0
Ryde Hospital - Eastwood
Recruitment postcode(s) [1] 27768 0
2065 - St Leonards
Recruitment postcode(s) [2] 27767 0
2077 - Hornsby
Recruitment postcode(s) [3] 27766 0
2103 - Mona Vale
Recruitment postcode(s) [4] 27769 0
2122 - Eastwood

Funding & Sponsors
Funding source category [1] 303668 0
Hospital
Name [1] 303668 0
Chronic Disease Community Rehabilitation Service, Northern Sydney Local Health District
Country [1] 303668 0
Australia
Primary sponsor type
Hospital
Name
Chronic Disease Community Rehabilitation Service, Northern Sydney Local Health District
Address
The Lodge. Macquarie Hospital. Corner Twin & Badajoz Rd. North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 303852 0
None
Name [1] 303852 0
Address [1] 303852 0
Country [1] 303852 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304189 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 304189 0
Kolling Institute
Level 13 Kolling Building, Royal North Shore Hospital, St Leonards, NSW, 2065
Ethics committee country [1] 304189 0
Australia
Date submitted for ethics approval [1] 304189 0
Approval date [1] 304189 0
15/04/2019
Ethics approval number [1] 304189 0
2019/ETH00414

Summary
Brief summary
The primary objective of this study is to determine if nutritional supplementation improves exercise capacity in patients with Chronic Obstructive Pulmonary Disease (COPD) attending pulmonary rehabilitation.
Secondary aims of this study are to evaluate if nutritional supplementation results in greater improvements in hand grip strength, body weight, body mass index (BMI), nutritional status (MNA), health related quality of life and lower limb strength in people with COPD participating in pulmonary rehabilitation.
Participants will attend an 8 week (16 session) pulmonary exercise rehabilitation program which consists of two 1.5 hour exercise sessions per week.
Participants that consent to take the nutritional supplement will be assigned to the intervention group and will be asked to take a nutritional supplement daily for the period of their 8-week exercise rehabilitation program.
Participants who decline to take the nutritional supplement will be invited to also take part in the study and will be assigned to the Control Group (non-randomised) and asked to complete baseline and follow up outcome measures only.
Overseas studies have shown that nutritonal supplements improve exercise outcomes for patients with COPD attending pulmonary rehabilitation and we aim to see if this can be replicated in the Australian population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96090 0
Ms Irene Rulli
Address 96090 0
The Lodge. Macquarie Hospital. Corner Twin & Badajoz Rd. North Ryde NSW 2113.
Country 96090 0
Australia
Phone 96090 0
+61409461156
Fax 96090 0
Email 96090 0
irene.rulli@health.nsw.gov.au
Contact person for public queries
Name 96091 0
Ms Irene Rulli
Address 96091 0
The Lodge. Macquarie Hospital. Corner Twin & Badajoz Rd. North Ryde NSW 2113.
Country 96091 0
Australia
Phone 96091 0
+61409461156
Fax 96091 0
Email 96091 0
irene.rulli@health.nsw.gov.au
Contact person for scientific queries
Name 96092 0
Ms Irene Rulli
Address 96092 0
The Lodge. Macquarie Hospital. Corner Twin & Badajoz Rd. North Ryde NSW 2113.
Country 96092 0
Australia
Phone 96092 0
+61409461156
Fax 96092 0
Email 96092 0
irene.rulli@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.