Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001395123p
Ethics application status
Not yet submitted
Date submitted
24/09/2019
Date registered
11/10/2019
Date last updated
11/10/2019
Date data sharing statement initially provided
11/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of different weight lifting sessions on shortness of breath in individuals with advanced lung cancer
Scientific title
Impact of different RESisTance exercise configurations on dyspnea, and psychosocial response in individuals with advanced LUNG cancer.
Secondary ID [1] 299388 0
Nil
Universal Trial Number (UTN)
Trial acronym
REST-LUNG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 314563 0
Condition category
Condition code
Cancer 312898 312898 0 0
Lung - Small cell
Cancer 312899 312899 0 0
Lung - Non small cell
Cancer 312900 312900 0 0
Lung - Mesothelioma
Physical Medicine / Rehabilitation 313007 313007 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a within-subject, repeated measures design, with participants serving as their own controls, completing both experimental conditions. This study is designed to compare the effects of two different resistance exercise RE configurations on dyspnea and affective responses in individuals with a diagnosis of advanced lung cancer Participation in this study will involve one baseline assessment and two experimental conditions.

The baseline assessment will be used to perform 10 repetition maximum testing for each of the exercises to determine the load used for both experimental conditions. Participants will begin testing for each exercise by completing a warm-up set of 4-6 repetitions. Participants will then perform multiple sets of each exercise with stepwise increases in weight until they performed the lift with the maximal amount of weight with correct form for 10 repetitions. Patients will be allowed 2-3 minutes of rest between 10-RM effort attempts. This session is anticipated to last approximately 60 minutes. The intensity for each experimental condition will be defined by this 10RM load, using 100% 10RM.

Each of the experimental conditions will involve a series of 3 exercises targeting both the upper and lower body. Specifically, the exercises will include leg press, seated row and chest press. Three sets of each exercise will be performed in each session for both conditions, whereas the rest taken during each set will differ in each experimental condition.

Each session will be performed in one-on-one fashion, supervised by an exercise physiologist with extensive experience delivering exercise interventions for individuals with cancer. Each session will last approximately 45-60 minutes.

The traditional set (TS) will be completed with no intra-set rest, completing all 10 repetitions consecutively in each set. The cluster set (CS) will allow for intra-set rest of 20 seconds with every 2 consecutive repetitions, until 10 total repetitions have been reached. The traditional set will include 3 x 10 reps with no intra-set rest for each exercise, cluster set will include 3 x 10 reps with an intra-set rest of 20 seconds every 2 reps. The order of experimental conditions will be randomized and counterbalanced across patients. Each condition will have a washout period of at least 72-hours.
Intervention code [1] 315646 0
Lifestyle
Intervention code [2] 315706 0
Treatment: Other
Intervention code [3] 315707 0
Rehabilitation
Comparator / control treatment
The cluster set is the comparator for this trial. As mentioned above, cluster sets with additional rest will be compared to traditional sets with traditional rest periods.

The traditional set (TS) will be completed with no intra-set rest, completing all 10 repetitions consecutively in each set. The cluster set (CS) will allow for intra-set rest of 20 seconds with every 2 consecutive repetitions, until 10 total repetitions have been reached. The traditional set will include 3 x 10 reps with no intra-set rest for each exercise, cluster set will include 3 x 10 reps with an intra-set rest of 20 seconds every 2 reps. The order of experimental conditions will be randomized and counterbalanced across patients. Each condition will have a washout period of at least 72-hours.
Control group
Active

Outcomes
Primary outcome [1] 321501 0
Affect (Feeling Scale)

Affective responses to the exercise will be assessed using the FS, a single-item measure tapping participants’ immediate global ratings of pleasure-displeasure on a scale ranging from -5 (very bad) to 0 (neutral) to +5 (very good).
Timepoint [1] 321501 0
Before exercise, after the 5th repetition of each set, after the 3rd set of every exercise, immediately following (primary endpoint) and 30 minutes following the end of the exercise session.
Secondary outcome [1] 375198 0
Dyspnoea
A Visual analog scale (VAS) will be used to assess perceptions of air hunger, prior to and following each experimental condition.

VAS is a 100mm line anchored with “no symptoms” at 0mm and “maximum possible symptoms” at 100mm and participants will be asked to make a mark along the line at a point representing their level of air hunger, effort and shortness of breath. All VAS scores will be measured by two independent researchers and the scores averaged. If the two measurements differ by more than 3mm, both measurements will be repeated by the same observers.
Timepoint [1] 375198 0
Before exercise, immediately following and 30 minutes following the end of the exercise session.
Secondary outcome [2] 375201 0
Barrier Self-efficacy. Participants’ confidence in their ability to overcome symptoms such as fatigue and dyspnea to participate in resistance exercise will be assessed with a 10-point Likert scale.
Timepoint [2] 375201 0
Before exercise, immediately following and 30 minutes following the end of the exercise session.
Secondary outcome [3] 375392 0
A Visual analog scale (VAS) will be used to assess perceptions of effort prior to and following each experimental condition.

VAS is a 100mm line anchored with “no symptoms” at 0mm and “maximum possible symptoms” at 100mm and participants will be asked to make a mark along the line at a point representing their level of effort. All VAS scores will be measured by two independent researchers and the scores averaged. If the two measurements differ by more than 3mm, both measurements will be repeated by the same observers.
Timepoint [3] 375392 0
Before exercise, immediately following and 30 minutes following the end of the exercise session.
Secondary outcome [4] 375393 0
A Visual analog scale (VAS) will be used to assess perceptions of air hunger prior to and following each experimental condition.

VAS is a 100mm line anchored with “no symptoms” at 0mm and “maximum possible symptoms” at 100mm and participants will be asked to make a mark along the line at a point representing their level of air hunger. All VAS scores will be measured by two independent researchers and the scores averaged. If the two measurements differ by more than 3mm, both measurements will be repeated by the same observers.
Timepoint [4] 375393 0
Before exercise, immediately following and 30 minutes following the end of the exercise session.

Eligibility
Key inclusion criteria
Individuals with a diagnosis of advanced lung cancer (i.e., stage IIIB-IV Non small cell lung cancer, extensive disease small cell lung cancer, or confirmed malignant pleural effusion) will be recruited to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1) Age <18 years;
2) Inability to read and understand English. Participants will be required to complete questionnaire assessments and understand instructions, which require that individuals are able to read English;
3) Unable to obtain physician consent;
4) Acute illness or any musculoskeletal, cardiovascular or neurological disorder that could inhibit or put participants at risk from participating in assessments or exercise intervention as determined by the patients specialist;
5) Presence of unstable bone or brain metastases;
6) Inability to give informed consent or comply with the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2020
Actual
Date of last participant enrolment
Anticipated
1/10/2020
Actual
Date of last data collection
Anticipated
27/10/2020
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14852 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 28115 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 303900 0
University
Name [1] 303900 0
Edith Cowan University
Country [1] 303900 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr, Joondalup WA, 6027
Country
Australia
Secondary sponsor category [1] 304048 0
None
Name [1] 304048 0
Address [1] 304048 0
Country [1] 304048 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304406 0
Sir Charles Gairdner Hospital Health Research Ethics Commitee
Ethics committee address [1] 304406 0
Ethics committee country [1] 304406 0
Australia
Date submitted for ethics approval [1] 304406 0
14/11/2019
Approval date [1] 304406 0
Ethics approval number [1] 304406 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96838 0
Dr Ciaran Fairman
Address 96838 0
Edith Cowan University, 270 Joondalup Dr, Joondalup, WA, 6027
Country 96838 0
Australia
Phone 96838 0
+61452268416
Fax 96838 0
Email 96838 0
[email protected]
Contact person for public queries
Name 96839 0
Ciaran Fairman
Address 96839 0
Edith Cowan University, 270 Joondalup Dr, Joondalup, WA, 6027
Country 96839 0
Australia
Phone 96839 0
+61863043672
Fax 96839 0
Email 96839 0
[email protected]
Contact person for scientific queries
Name 96840 0
Ciaran Fairman
Address 96840 0
Edith Cowan University, 270 Joondalup Dr, Joondalup, WA, 6027
Country 96840 0
Australia
Phone 96840 0
+61863043672
Fax 96840 0
Email 96840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Data will be available after publication for a period of 7 years
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal,
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]; 0863043672)


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.