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Trial registered on ANZCTR


Registration number
ACTRN12616001512415
Ethics application status
Approved
Date submitted
6/05/2016
Date registered
1/11/2016
Date last updated
27/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise training in patients with non-small cell lung cancer during in-hospital chemotherapy treatment: a randomized controlled trial.
Scientific title
Effect of hospital based physiotherapy for patients undergoing in-hospital chemotherapy for non-small cell lung cancer on physical fitness, dyspnea and quality of life
Secondary ID [1] 289152 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lung cancer 298680 0
Condition category
Condition code
Cancer 298734 298734 0 0
Lung - Non small cell
Physical Medicine / Rehabilitation 299090 299090 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this project, it was proposed to examine the relationship between comprehensive hospital based physiotherapy in patients with non-small-cell lung carcinoma during cytostatic treatment and its impact on physical fitness, patient endurance, health related quality of life, dyspnea and fatigue.
The 60 patients were enrolled to research, 20 excluded. 40 randomized , 26 allocate to ETG and 14 to CG, diagnosed within the last 6 weeks, or with earlier stage of the disease, excluded from surgery or radiation), confirmed by cytology or histology test results. The research study took place at the Independent Public Clinical Hospital No. 3 of Medical University of Silesia in Katowice.
The ETG group: Based on the initial 6MWT and spirometry results, subjects participated in two, two-weeks periods of rehabilitative exercise therapy, supervised by certified Physiotherapist. Before first 2-weeks rehabilitation program and between these two periods, patients proceed to scheduled chemotherapy in hospital condition.The CG group: There were a 6 week period between initial and final assessments; during the middle two weeks patients proceed to a scheduled chemotherapy period.
Patients participated in exercise sessions 5 times per week. Sessions consisted of:
Morning exercises
1. (8:30-9:00 am) specific respiratory exercises for 30 minutes - relaxation exercises for breathing muscles, strengthening exercises the diaphragm with resistance, exercises to increase costal or chest breathing, prolonged exhalation exercise, chest percussion
2. (10:00-10:30 am) 30 minutes of fitness and respiratory exercises - coordination and balance exercises, stretching exercises using elastic bands, balls rehabilitation, sensory pillows. Performed in a standing position, kneeling, sitting, lying on side, abdomen and back.
3. (11:00-11:30 am) training on a cycle ergometer or treadmill for 20-30 minutes, intensity 30% - 80% peak work rate.
Afternoon exercises
4. (1:00-1:30 pm) Resistance exercise intensity 40% - 70% 1RM,
5. (3:00-4:00 pm) Nordic walking for 45 minutes (depending on weather and health condition of the patient),
6. (4:00 pm) relaxation training - Autogenic training is a desensitation-relaxation technique developed by the German psychiatrist Johannes Heinrich Schultz. The technique involves the daily practice of sessions that last around 15 minutes. During each session, the practitioner repeats a set of visualisations that induce a state of relaxation. Each session can be practiced in a position chosen amongst a set of recommended postures (for example, lying down, sitting meditation, sitting like a rag doll). The technique can be used to alleviate many stress-induced psychosomatic disorders.
Heart rate and O 2 saturation were monitored continuously throughout sessions exercise and blood pressure was assessed intermittently.
The change of the number of participants enrolled/randomised was made after enrolment of 5 participants
Intervention code [1] 294673 0
Rehabilitation
Comparator / control treatment
The patients of the control group will be assesses before and after 6 weeks of chemotherapy alone.
Control group
Active

Outcomes
Primary outcome [1] 298213 0
physical fitness (endurance, fatigue) assessed using Functional Fitness Test
Timepoint [1] 298213 0
1. baseline - Initial assessment of the patient, Chemotherapy session (1 week home care)
2. 3 weeks - Assessment of the patient after rehabilitation– physical fitness assessment.
3. 6 weeks - Final assessment of patient after 6 weeks– including physical fitness assessment
Primary outcome [2] 299821 0
Lung function (composite of FEV1, FVC, FEV1%FVC) assessed using spirometry
Timepoint [2] 299821 0
1. baseline - Initial assessment of the patient,
2. 3 weeks - Assessment of the patient after rehabilitation– lung function assessment.
3. 6 weeks - Final assessment of patient after 6 weeks– lung function assessment
Primary outcome [3] 299822 0
dyspnea assessed using MRC, BDI, Borg Scale
Timepoint [3] 299822 0
1. baseline - Initial assessment of the patient,
2. 3 weeks - Assessment of the patient after rehabilitation– dyspnea assessment.
3. 6 weeks - Final assessment of patient after 6 weeks– dyspnoea assessment
Secondary outcome [1] 323552 0
quality of life assessed using St George's Respiratory Questionnaire, SF-36, Functional Assessment of Cancer Therapy - Lung (FACT-L)
Timepoint [1] 323552 0
1. baseline - Initial assessment of the patient,
2. 6 weeks - Final assessment of patient after 6 weeks– quality of life

Eligibility
Key inclusion criteria
ability to perform the 6 minute walk test, Eastern Cooperative Oncology Group performance status 0-1 and ability to complete self-questionnaires and willingness to participate/ cooperate in the study
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
uncontrolled hypertension or unstable coronary artery disease, anaemia (HB< 10g/dl), severe osteoarthritis and bone metastases or CNS metastases.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
2:1 assignment, to either the Exercise Trained Group (ETG) or the Control Group (CG)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The normality of the data was evaluated using the Shapiro-Wilk test. Student's t-test was used for normally distributed data and equal variances, and the Wilcoxon Signed Ranks test for non-normally distributed data with a statistically significant p value <0.05. To make inter-group comparisons of changes, the Mann-Whitney U-test was adopted. The effect size (d Cohena) of the differences were calculated (small if 0 = |d| = 0.5, medium if 0.5, |d| = 0.8, and large if |d| > 0.8).
Preliminary analysis showed that 19 participants were needed to achieve a statistical power of 90% to detect a medium effect (d = 0.796) in the principle variable to be compared (Fullerton Up and go) when assessed by a two-tailed t-test for dependent variables with a level of significance of 5%. Finally, we selected 20 participants to ensure that no data would be lost.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7863 0
Poland
State/province [1] 7863 0
Katowice

Funding & Sponsors
Funding source category [1] 293535 0
University
Name [1] 293535 0
Medical University of Silesia
Address [1] 293535 0
18 Medykow Street
40-752 Katowice
POLAND
Country [1] 293535 0
Poland
Primary sponsor type
University
Name
Medical University of Silesia
Address
18 Medykow Street
40-752 Katowice
POLAND
Country
Poland
Secondary sponsor category [1] 292352 0
None
Name [1] 292352 0
Address [1] 292352 0
none
Country [1] 292352 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294980 0
Ethics Committee of Silesian Medical University
Ethics committee address [1] 294980 0
Poniatowskiego 15 40-055 Katowice
Ethics committee country [1] 294980 0
Poland
Date submitted for ethics approval [1] 294980 0
04/12/2012
Approval date [1] 294980 0
04/12/2012
Ethics approval number [1] 294980 0
KNW/0022/KB1/184a/I/11/12

Summary
Brief summary
1. The patients diagnosed in last 6 weeks with non small cell lung cancer (NSCLC) in stage III or IV ( or in early advanced stage, disqualified from operation or radiotherapy), confirmed on the basis of result from cytological examination or histopathological. Cancer staging TNM from medical records ( x-ray and CT of thorax, ultrasonography of abdominal cavity).
2. Information for the patients about aims and principle in research and written consent of participation from the patients.
The aim of the study was to assess the effect of rehabilitation program conducted on fitness and exercise capacity, lung ventilatory function, quality of life and dyspnea. Additionally, possibility for rehabilitation in patients with advanced lung cancer was assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65666 0
Mrs Anna Rutkowska
Address 65666 0
Opole University of Technology
76 Proszkowska Street 45-758 Opole
Country 65666 0
Poland
Phone 65666 0
+48507541143
Fax 65666 0
Email 65666 0
a.rutkowska@po.opole.pl
Contact person for public queries
Name 65667 0
Mr Sebastian Rutkowski
Address 65667 0
Opole University of Technology
76 Proszkowska Street 45-758 Opole
Country 65667 0
Poland
Phone 65667 0
+48507027792
Fax 65667 0
Email 65667 0
s.rutkowski@po.opole.pl
Contact person for scientific queries
Name 65668 0
A/Prof Dariusz Jastrzebski
Address 65668 0
Medical University of Silesia in Katowice
41-803 Zabrze, ul. Koziolka 1
Country 65668 0
Poland
Phone 65668 0
+483732235
Fax 65668 0
Email 65668 0
darekjdr@poczta.onet.pl

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary