ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

lung cancer

Condition category

Condition code

Cancer

Lung - Non small cell

Physical Medicine / Rehabilitation

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]

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]

physical fitness (endurance, fatigue) assessed using Functional Fitness Test

Timepoint [1]

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]

Lung function (composite of FEV1, FVC, FEV1%FVC) assessed using spirometry

Timepoint [2]

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]

dyspnea assessed using MRC, BDI, Borg Scale

Timepoint [3]

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]

quality of life assessed using St George's Respiratory Questionnaire, SF-36, Functional Assessment of Cancer Therapy - Lung (FACT-L)

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/05/2015

Date of last participant enrolment

Anticipated

Actual

23/08/2016

Date of last data collection

Anticipated

Actual

5/10/2016

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Katowice

Funding & Sponsors

Funding source category [1]

University

Name [1]

Medical University of Silesia

Address [1]

18 Medykow Street
40-752 Katowice
POLAND

Country [1]

Poland

Primary sponsor type

University

Name

Medical University of Silesia

Address

18 Medykow Street
40-752 Katowice
POLAND

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of Silesian Medical University

Ethics committee address [1]

 Poniatowskiego 15 40-055 Katowice

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

04/12/2012

Approval date [1]

04/12/2012

Ethics approval number [1]

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

Attachments [1]

/AnzctrAttachments/370652-ETHICS COMMITTEE OF MEDICAL UNIVERSITY OF SILESIA.pdf

Attachments [2]

/AnzctrAttachments/370652-ETHICS COMMITTEE OF MEDICAL UNIVERSITY OF SILESIA EN.pdf

Contacts

Principal investigator

Name

Mrs Anna Rutkowska

Address

Opole University of Technology
76 Proszkowska Street 45-758 Opole

Country

Poland

Phone

+48507541143

Fax

a.rutkowska@po.opole.pl

Contact person for public queries

Name

Sebastian Rutkowski

Address

Opole University of Technology
76 Proszkowska Street 45-758 Opole

Country

Poland

Phone

+48507027792

Fax

s.rutkowski@po.opole.pl

Contact person for scientific queries

Name

Dariusz Jastrzebski

Address

Medical University of Silesia in Katowice
41-803 Zabrze, ul. Koziolka 1

Country

Poland

Phone

+483732235

Fax

darekjdr@poczta.onet.pl

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Exercise Training in Patients With Non-Small Cell Lung Cancer During In-Hospital Chemotherapy Treatment: A RANDOMIZED CONTROLLED TRIAL.	2019	https://dx.doi.org/10.1097/HCR.0000000000000410
Embase	Short-term changes in quality of life in patients with advanced lung cancer during in-hospital exercise training and chemotherapy treatment: A randomized controlled trial.	2021	https://dx.doi.org/10.3390/jcm10081761

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically