Nordic Pole Walking for Individuals With Cancer: A Feasibility Study Assessing Physical Function and Health-Related Quality of Life
Phase: NA
Conditions: Cancer, Neoplasms
Sponsor: University of Ontario Institute of Technology

Elise Cunningham 
Pilot Study: Nordic Pole Walking & Lung Cancer 
Research Proposal 
 
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1.0 
Title of Research Project: 
Pilot Study on Nordic Pole Walking and Individuals with Non-Small Cell Lung Cancer: Effects 
on Physical Function and Quality of Life 
2.0 
Rationale: Statement of Need 
Research has shown that patients fear disability more than other complications that 
result from Non-Small Cell Lung Cancer (NSCLC) or its treatments(1). Lung cancer patients 
experience a high symptom burden including dyspnea, cough, fatigue, and pain(2). Patients also 
struggle with sleep disturbances, anxiety, depression and fear as well as reporting impaired 
quality of life(3). Upon diagnosis patients with NSCLC have decreased physical activity levels 
and over time a continuing cycle of inactivity and functional decline as strength and 
cardiovascular fitness deteriorates with worsening symptoms(4, 5). As a result, exercise is being 
recognized for its potential to improve overall function in addition to increased longevity in this 
population(6, 7). 
The benefits of exercise training have been well documented in other chronic respiratory 
disease populations such as individuals with chronic obstructive pulmonary disease or 
interstitial lung disease (8, 9) and may also benefit the NSCLC population. Studies have shown 
exercise interventions are safe, feasible and well tolerated by patients with NSCLC (10-12), but 
further research is needed to understand the effectiveness of specific exercise interventions (12, 
13). There is also a need for further exploration of outcomes such as health related quality of 
life (HRQoL), fatigue, pain, dyspnea and fear of recurrence. Furthermore, there remains a lack 
of knowledge regarding the sustainability and long-term effects of exercise on this population 
(12). This knowledge would help to guide clinicians and policymakers in their efforts to 
improve quality of life in this patient population. 
3.0 
Background and Literature:  
3.1 
Epidemiology of Lung Cancer in Canada: In 2014 it is estimated that 26,100 people in Canada 
were newly diagnosed with lung cancer(14). This accounts for about 13.6% of all new cancer 
diagnoses(14). Lung cancer is the leading cause of cancer related deaths in Canada. About 
20,500 people were expected to die of lung cancer in 2014: more than breast, prostate and 
colorectal cancers combined(14). Cancer is considered to be the third most costly disease after 
cardiovascular and musculoskeletal diseases(15); cancer care in Canada was estimated to cost 
$14.2 billion in 1998(15). A study published in 2013 looking at cancer costs in Ontario 
reviewed the costs of 402,399 patients who were 19 years of age and older and had been 
diagnosed with different cancers(15). It was determined that the overall mean cost per lung 
cancer patient during the first year post-diagnosis was $31,550 (2009 Canadian dollars)(15). 
This study also found that lung cancer (together with colorectal breast and prostate cancers) 
presented the largest financial burden to the Ontario health care system with hospital 
admissions being the greatest contributor to these high costs(15). Other resource categories that 
contributed significantly to the cost were chemotherapy, physician services and diagnostic 
testing(15). 
3.2 
Pathophysiology of Lung Cancer: Lung cancer is a malignant tumour that originates in the cells 
of the lungs(16). Individuals who have been exposed to tobacco smoke, asbestos and radiation 
are at increased risk of developing lung cancer(16). Ninety percent of people diagnosed with 
lung cancer are asymptomatic and hemoptysis (the coughing up of blood) is the most common 

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first sign(16). 
Lung cancer is classified as either small cell lung cancer or NSCLC. Small cell lung 
cancer originates in the bronchi in the centre of the lung and is the most aggressive of all types 
of lung cancer, usually resulting in metastases to other parts of the body(16). It comprises 
approximately 10 to 15% of all lung cancer cases(16).  
NSCLC is the most common type of lung cancer accounting for 85 to 90% of all 
cases(16). There are three main types of NSCLC: 1) adenocarcinoma (usually begins in the 
periphery of the lung), 2) squamous cell carcinoma (almost always found in people with a 
history of smoking and is usually located in the large bronchi near the centre of the lung), and 
3) large cell carcinoma (least common type of NSCLC)(16). The earlier NSCLC is diagnosed 
and treated the better the prognosis(16). Upon diagnosis NSCLC is classified based on the 
extent of cancer in the body using the “tumour, nodes, metastasis” (TNM) system(16). This 
system outlines the size of the primary tumour, the number and location of any regional lymph 
nodes that have cancer cells in them, and whether the cancer has metastasized to another part of 
the body(16). There are four stages in the TNM classification system and the first three stages 
are divided into A and B subgroups where the prognosis of B is progressively worse than 
A(16). The following descriptions of each stage can be applied to most NSCLC diagnosis: i) 
Stage I: Tumours are less than 3 cm in diameter and are completely within the lung. ii) Stage II: 
Tumours have metastasized to the bronchial or hilar lymph nodes. iii) Stage III: Tumours have 
metastasized to the mediastinal lymph nodes. iv) Stage IV: Tumours have metastasized to the 
pleura, the other lung or to other organs outside of the chest(16).  
Depending on the stage of cancer, health history and functional ability treatments for 
NSCLC include lung resection, chemotherapy, radiation therapy or a combination thereof(16). 
The survival rate of those diagnosed with NSCLC is considerably better than those diagnosed 
with small cell lung cancer. Forty percent of NSCLC patients who undergo complete lung 
resection of the primary tumour survive up to five years(16). For those diagnosed with small 
cell lung cancer, lung resection is rarely an option and median survival rates range from 313 to 
388 days(16). This research project will include patients who have been diagnosed with NSCLC 
because of its higher prevalence and survival rate. 
3.3 
Exercise & Lung Cancer: Exercise interventions for NSCLC patients pre- and post-surgery have 
been determined safe, feasible and well tolerated, even in those with advanced and metastatic 
disease (10-12). Additionally, low to moderate intensity exercise was found to be well tolerated 
in patients with NSCLC who underwent chemotherapy and/or radiation treatment (17, 18). 
Recent reviews of physical activity and exercise in lung cancer report that exercise has been 
shown to reduce symptoms, increase exercise tolerance, improve quality of life and potentially 
reduced length of stay and post-operative complications(19, 20). To better understand exercise 
as applied to NSCLC patients there is a need to generalize according to the specific populations 
that are studied (perioperative and advanced disease). 
1) Perioperative Exercise: In 2013 a Cochrane review identified three RCTs involving 178 
participants who had participated in an exercise intervention within 12 months of lung 
resection for NSCLC(13). The review reported that exercise capacity as measured by the 
six-minute walk test (6MWT) as greater in the intervention group compared to the control 
group (mean difference (MD) 50.4m; 95% confidence interval (CI) 15.4 to 85.2m)(13). 
There was no reported difference in HRQoL between groups (standardized mean difference 
(SMD) 0.17; 95% CI -0.16 to 0.49)(13). Authors noted that the results of this review should 
be interpreted with caution due to significant risks of bias and small sample sizes(13). Only 
one of the studies described blinding of outcome assessors and all of the studies were found 
to have evidence of performance bias(13). The quality of evidence in this research area is 

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negatively affected by the limited number of RCTs that have been done(13). 
Three systematic reviews investigated the effect of exercise in the NSCLC population. 
Granger et al. (2011) systematically reviewed the literature (n=675, 2 RCTs, 8 prospective 
case series, a retrospective case series, a prospective cohort trial and a retrospective cohort 
trial)(21). Interventions included aerobic training, resistance training, stretching exercises 
or a combination thereof and outcomes included exercise capacity, HRQoL and safety (21). 
Overall NSCLC patients benefited from exercise interventions pre-operatively or post-
cancer treatment including surgery, chemotherapy and radiation treatment as exercise 
capacity, symptoms were found to improve(21). General HRQoL was also affected(21). 
Exercise was also found to be safe for NSCLC patients before and after cancer 
treatment(21).  
Crandall et al. (2014) systematically reviewed the literature (n=575, 8 RCTs, 10 single 
group trials) on exercise interventions for lung cancer patients who were surgically 
treated(12). Studies included in this review involved exercise interventions that were 
supervised or unsupervised inpatient, outpatient, community or home-based(12). 
Researchers concluded that exercise led to improved cardiopulmonary exercise capacity, 
increased muscle strength and reduced fatigue, post-operative complications and hospital 
length of stay in patients with resectable NSCLC(12). Three RCT’s measured the effects of 
post-operative exercise programs on HRQoL and found no significant difference between 
groups. However, differences in HRQoL measurement tools (generic/specific), intervention 
designs and the extent of surgery made comparison between studies difficult(12). Future 
studies need to use equal measurement tools that have been proven to be reliable and valid 
within the specific patient population(12).  
Rodriguez-Larrad et al. (2014) conducted a systematic review (n=599, all 8 studies were 
RCTs) examining the use of perioperative respiratory physiotherapy in patients who 
underwent pulmonary resection for lung cancer(22). Some study interventions included 
chest physiotherapy or intermittent positive pressure breathing only while others also 
involved aerobic and resistance training(22). Each study included in the review examined at 
least two or more of the following outcome variables: functional capacity, postoperative 
pulmonary complications (PPC) or prolonged length of hospital stay (LOS)(22). Pre-
operative aerobic exercise in patients undergoing lung cancer resection was found to 
improve functional capacity and reducing postoperative morbidity(22). The addition of 
aerobic and resistance training to the usual care or standard physiotherapy in the post-
operative period did not reduce PPC or LOS in patients undergoing lung resection(22). 
These results should be taken with caution because of the high variability in the types of 
interventions used; it is not possible to establish the effectiveness of each individual 
intervention(22).  
To summarize, evidence indicates that perioperative exercise is safe and that exercise 
may benefit the exercise capacity and HRQoL of lung cancer patients. Due to significant 
between-study heterogeneity within the systematic reviews, it was inappropriate to conduct 
meta-analyses and pool results(12, 21, 22). Future research should continue to analyze 
various types of exercise in order to inform the optimum exercise prescription and setting 
for NSCLC patients. In addition larger sample sizes, clear reporting structure and adequate 
allocation concealment should also be considered. 
2) Advanced Disease: Patients with advanced stages (IIIA, IIIB, IV) of NSCLC have notably 
decreased exercise capacity. Yilmaz et al (2013) determined this to be a result of decreased 
pulmonary function and peripheral muscle strength(4). In addition reduced exercise capacity 
negatively impacts functional categories of HRQoL in these patients(4).  Holland et al. 

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(2013), believed that the combination of symptoms, including diminished muscle strength, 
decreased HRQoL, increased dyspnea and greater levels of fatigue provide a strong 
rationale for referring this patient population to a pulmonary rehabilitation program(23).  
In 2013 Cheville et al. in a RCT (n=66) examined the effects of a home-based walking 
and strength training exercise program (versus usual care) on function, fatigue and sleep 
quality in patients with stage IV lung and colorectal cancer(24). Twenty out of 26 of the 
participants in the intervention group adhered to the program. They showed improvement in 
mobility (p=0.01), fatigue (p=0.02) and sleep quality (p=0.05) over time. The mean changes 
(from baseline to week eight) between the intervention and control groups in mobility 
(p=0.002), fatigue (p=0.03), and sleep quality (p=0.002) also significantly differed. (24). 
Henke et al. (2014) also conducted a RCT (n=46) to test the effects of strength and 
endurance training on the independence and quality of life in lung cancer patients with 
advanced disease during three cycles of palliative chemotherapy treatment(25). The 
intervention group (n=18) participated in cardiovascular exercise daily and strength training 
every other day(25); the control group (n=11) received conventional physiotherapy 
consisting of manual therapy and breathing techniques(25). Out of 46 patients only 29 
completed the trial; 17 patients ended the trial early due to death (n=6), non-compliance 
(n=10) or because they continued treatment at a different hospital (n=1)(25). A significant 
difference between groups was found in physical function, self-reported symptoms (pain, 
neuropathy, cognitive functioning, dyspnea) and exercise capacity(25).  
This evidence suggests that exercise capacity and symptom burden in patients with 
advanced lung cancer can be improved with exercise, however frequency, duration and 
intensity of prescription are not certain. Most studies on exercise in this population have 
consisted of in-hospital supervised exercise programs, which may be restrictive to some 
patients and has been associated with poor compliance. There is a need to further examine 
home-based exercise programs including new modalities of exercise that may not have been 
accessible in the clinical setting(26). 
3.4 
Nordic pole walking:  Nordic pole walking (NPW) is a low-impact form of exercise that 
involves walking with a pair of poles customized to the participant’s height and stride length. 
While NPW has become an increasingly popular type of exercise, little research has been done 
to determine the effects of NPW on the cancer population let alone the NSCLC patient 
population.  Tschentscher et al. (2013) conducted a systematic review to summarize and 
interpret the health benefits of NPW and to compare the effects of NPW to brisk walking and 
jogging on heart rate, maximal oxygen consumption (VO2max), HRQoL and other health 
measurements in healthy and chronic disease populations(27). Included in this review were 16 
RCTs (n=1062) and 11 observation studies (n=831)(27). Two RCTs on healthy subjects were 
included in the review(28, 29). Kukkonen-Harjula et al. (2007) conducted an RCT (n=121) 
investigating the effects of a self-guided 12-week (40 minutes, 4 times per week) program 
involving NPW (n=60) and walking (n=61) on health-related fitness in 50-60 year old sedentary 
women(29). Improvement was recorded in maximum heart rate, respiratory exchange ratio, 
VO2max, and lactate threshold, but there was no between group difference found(29). The 
second RCT (n=168) by Hagner et al. (2009) examined the physiological effects of 
premenopausal (n=65), perimenopausal (n=53), and postmenopausal (n=53) women 
participating in a twelve week NPW program that consisted of three 90-minutes sessions of 
NPW per week(28). For all of the groups studied there was a significant increase in VO2max 
and high-density lipoprotein (HDL) and a reduction in total cholesterol, low-density lipoprotein 
(LDL), triglycerides and BMI (p<0.01)(28) over time. No group differences were reported and 
there was no control group. These results demonstrated that NPW combined with an effort to 

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maintain a healthy diet significantly influences the well being of premenopausal, 
perimenopausal and postmenopausal women over time (28). Several observational studies have 
supported the results of these two RCTs by showing similar short-term effects of NPW in the 
healthy population including increased VO2, higher peak heart rate, raised respiratory 
exchanged ratio and higher energy expenditure than brisk walking at the same pace(30-32). 
Tschentscher et al. also looked at the effects of NPW on different chronic disease 
populations including those with COPD(33) and breast cancer(34). A RCT (n=60) conducted by 
Breyer et al. (2010) measured the short- and long-term effects of NPW on COPD patients’ daily 
physical activity levels and exercise capacity. The NPW group (n=30) trained for 60-minutes 
three times per week at an intensity of 75% of maximum heart rate, compared to the sedentary 
control group (no poles or exercise) (n=30). Daily physical activity and the 6MWT increased 
with NPW (both p<0.01). Furthermore, NPW decreased exercise-induced dyspnea (Borg 
dyspnea score) and anxiety and depression (Hospital Anxiety and Depression Scale) and 
improved HRQoL (SF-36 Physical Component Summary and Mental Component Summary; all 
p<0.01). There were no changes in lung function parameters or medication use. In addition 
another research study by Barberan-Garcia et al. (2015) (cross-sectional design; n=16) 
compared the physiological response during NPW on solid ground and beach sand to regular 
walking in the COPD population(35). NPW on solid ground and beach sand resulted in higher 
VO2 plateaus compared with the 6MWT (no poles) and peak VO2 during the incremental 
shuttle test (p<0.05 each)(35). There was no difference in rate of perceived exertion (RPE) 
observed between NPW on solid ground compared to the 6MWT and the incremental shuttle 
test, however RPE during NPW on beach sand was significantly higher than all other exercise 
protocols (p<0.05)(35). This study showed that NPW could generate higher VO2 compared to 
regular walking in COPD patients with little influence on dyspnea. Therefore it might be a 
suitable way to enhance community-based training programs in COPD patients(35). 
Sprod et al. (2005) completed an RCT (n=12) to compare the effects of an 8-week NPW 
exercise program on shoulder range of motion (ROM) and upper body muscular endurance in 
breast cancer survivors(34). The intervention group (n=6) participated in 20-minutes of NPW 
outdoors twice per week, while the control group (n=6) walked outdoors without poles twice 
per week(36). As part of the program both groups performed 30-minutes of resistance training 
and concluded with stretching exercises(36). The intervention group demonstrated significant 
improvement (p<0.05) in upper body muscular endurance on bench press and lat pull down 
exercises over the 8-week study, while the control group showed no significant change over the 
same time period(36). The between group differences were not reported. This study indicates 
that for breast cancer survivors NPW is more beneficial than regular walking as it results in an 
improved muscular endurance of the shoulder muscles(34). 
In summary, the research above suggests that the short-term and long-term effects of 
NPW are beneficial to both the healthy population and those with COPD and breast cancer. 
However, due to small sample sizes and poor methodological quality caution should be used 
when drawing conclusions from these studies. 
3.5 
The Pilot Study: Pilot studies are conducted to assess feasibility prior to conducting a large-
scale investigation(37). They are an important step in the research process. The purpose of 
running a pilot study is usually related to trialing a study design and/or testing a new instrument 
and establishing that investigators understand the research protocol and are able to collect data 
in a consistent manner(38). Specific rationale for performing a pilot study can be classified into 
four categories: i) Process: To assess operational processes that take place within the study(37). 
For example, determining recruitment rates and retention rates. ii) Resources: To assess any 
difficulties that may occur related to time and budget(37). For example, the length of time it 

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takes for participants to complete questionnaires. iii) Management: To observe any potential 
human and data optimization problems that may occur(37). For example, issues that may arise 
at participating centres. iv) Scientific: To assess treatment safety, determine dose levels and 
response and estimate treatment effect and its variance(37). While pilot studies have little to 
contribute statistically and theoretically, they provide extensive understanding of the research 
process(38). Therefore, researchers need to remain open-minded, using the results of the pilot 
study to adapt the design and operational processes of a full study(38). 
3.6 
Knowledge Gaps and Contribution to Research: There is a growing body of evidence 
supporting exercise in the NSCLC population and health care professionals are encouraged to 
recommend that NSCLC patients participate in an exercise program. However, there is a need 
to establish the most appropriate and effective exercise prescription for this population. 
Currently, there is insufficient evidence regarding the optimal exercise type and prescription for 
the NSCLC population(12). To assist health care professionals with making exercise 
recommendations for this population more rigorous, methodological studies (i.e. RCTs) 
examining the effects of various exercise types and prescriptions, such as resistance training and 
Nordic pole walking are needed. To accomplish this a feasibility or pilot study is required to 
establish the optimal study design, population, assessment tools, interventions and operational 
processes. It has been recognized that poor accessibility to rehabilitation programs for lung 
cancer patients is a barrier to exercise program participation (ref Didier). Therefore future 
studies should consider home-based programs particularly for those with advanced disease. 
NPW has been selected as an appropriate exercise for NSCLC patients because of its 
ability to be a more intense and beneficial exercise compared to regular walking(27). It also 
allows patients to exercise independently. A study of individual/group exercise using NPW will 
be the first of its kind and is the first step to establishing the appropriate NPW exercise 
prescription including the optimal frequency, intensity and time spent NPW for individuals with 
NSCLC. 
4.0 
Research Objectives, Questions & Hypotheses 
The primary research question is: 1) What is the optimal design (patient sample, 
instruments) and operational processes to assess the effects of NPW on individuals who have 
been diagnosed with stage I-IV NSCLC? Secondary research questions are: 2) How does 
participating in an eight-week Nordic pole walking program affect physical function, and 3) 
health related quality of life (HRQoL) of these individuals? 
The primary objective is to assess the feasibility of a NPW program for individuals with 
stage I-IV NSCLC by establishing the optimal design and operational processes. The secondary 
objectives are to: determine the effects of NPW on 1) physical function, and 2) HRQoL. 
Hypotheses are that the NPW program for individuals who have been diagnosed with 
stage I-IV NSCLC will: 1) be feasible; 2) improve physical function; and 3) improve the 
HRQoL.  
5.0 
Methods: 
5.1 
Study Design: This is an eight-week multi-centre randomized controlled pilot study to establish 
optimal study design and operational processes to inform a larger scale study(37, 38). The 
intervention group will participate in an individualized NPW program, while the control group 
continues their usual daily routine. The control group is necessary because it increases the 
reliability of the results by allowing researchers to compare the control group measurements to 
the intervention group measurements.  
5.2 
Location of Research:  

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1. Lakeridge Health, Oshawa, Ontario (n=5 intervention, n=5 control, approximate eligible 
population at Lakeridge is 300, this is based on current and new cases of lung cancer at 
the Durham Regional Cancer Centre) 
2. Southlake Regional Health Centre, Newmarket, Ontario (n=5 intervention, n=5 control) 
3. Abilities Centre, Whitby, Ontario (ATTACHMENT 1) 
4. Magna Centre, Newmarket, Ontario (ATTACHMENT 2) 
5.3 
Sample Selection: The inclusion criteria: 1) primary diagnosis of histologically confirmed stage 
I-IV NSCLC (with any concurrent cancer treatment), 2) approval of primary treating physician, 
and 3) ≥ 18 years old. The exclusion criteria: 1) not able to communicate in English, 2) unable 
to consent, e.g. incapable, and 3) use of Nordic walking poles on a regular basis within the last 
six months. We will presume the study participant is capable with respect to the research study 
unless we suspect incapacity exists based on: the physician’s assessment; direct observation of 
the person e.g., the person is confused, disoriented, depressed, psychotic, extremely anxious, 
unable to make a decision, intoxicated; or from information obtained from family or other 
caregivers. 
5.4 
Recruitment: We anticipate recruiting a minimum of 20 individuals with NSCLC (n=10 
intervention group, n=10 control group). It is important that the pilot study be representative of 
the target study population(37, 38). The sample size needs to be large enough to provide useful 
information about the feasibility of the study(37, 38). Recruitment and enrolment will take 
place from approximately November 2015 – April 2016. The recruitment procedures are as 
follows: 
1) Lakeridge Health: Potential study participants will be screened (ATTACHMENT 3) and 
introduced to the study by the primary treating physician (upon approval) and/or the staff 
(oncology nurses) during their clinical visits. These physicians and nurses are not 
investigators or paid personnel in the study. Potential participants will be provided with a 
study information page (ATTACHMENT 4) by the physicians or nurses to read at their own 
pace. Interested potential participants will be asked to contact the researchers about the 
study. Upon being contacted a research team member will explain the study and obtain 
verbal consent (ATTACHMENT6) over the telephone. Written consent (ATTACHMENT 
5) will be provided during the first face-to-face visit at the recreation centre. 
2) Southlake Regional Health Centre: Potential study participants will be screened 
(ATTACHMENT 7) and introduced to the study by the primary treating physician (upon 
approval) and the staff (oncology nurses) during their clinical visits. These physicians and 
nurses are not investigators or paid personnel in the study. Potential participants will be 
provided with an study information page (ATTACHMENT 4) by the physicians or nurses to 
read at their own pace. Interested potential participants will provide consent to the nurses to 
release their contact information to the research team. The name and contact information of 
participants will then be forwarded to the research team. Upon receipt of this information a 
research team member will explain the study and obtain verbal consent (ATTACHMENT6) 
over the telephone. Written consent (ATTACHMENT 5) will be provided during the first 
face-to-face visit at the recreation centre. 
3) Posters (ATTACHMENT 8) informing potential participants about the study will be 
displayed at Lakeridge Health, Southlake Health Centre and various community based 
cancer centres (eg. Wellspring Cancer Centre). If participants are interested they will be 
asked to contact the research team using the information on the poster, who will then 
explain the study and obtain verbal consent (ATTACHMENT 6) over the telephone. 
Participants will be asked to discuss the study with and obtain approval from their primary 

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treating physician at their next follow-up appointment. Written consent (ATTACHMENT 5) 
will be provided during the first face-to-face visit at the recreation centre. 
4) NPW Information Sessions will be held at the recreation facilities where the NPW program 
will take place (Abilities Centre & Magna Centre). The purpose of these information 
sessions is to allow potential participants the opportunity to learn more about NPW 
including the risks and benefits of participating in this activity. Research team members will 
demonstrate NPW, explain the study and answer any questions that potential participants 
may have. Any potential participants who are interested will then speak on an individual 
basis with research team member who will then thoroughly explain the study and obtain 
written consent (ATTACHMENT 5). Pariticipants will be asked to obtain approval from 
their primary treating physician at their next follow-up appointment.  
5) Other strategies: We expect the strategies above (especially the first two) will be our 
primary recruitment techniques. If we are experiencing problems with recruitment we will 
use a variety of other strategies to identify and recruit potential participants including: 
snowball referrals from clinician experts, professional societies (e.g., Respiratory Therapy 
Society of Ontario), and patient advocacy groups (e.g., Ontario Lung Association) and via 
social media specifically Twitter and Facebook (ATTACHMENT 34). Twitter is a 
successful tool not only for disseminating research findings but also for planning studies 
and recruiting participants (e.g. the research of Marina Bastawrous @mbastaw). 
5.5 
Outcomes: 
5.5.1 Feasibility: The feasibility objectives for this pilot study are to:  
1. verify recruitment, consent and randomisation procedures; 
2. confirm the sample size required for a fully study;  
3. confirm the inclusion/exclusion process; 
4. test the appropriateness of assessment tools used in the study; 
5. determine appropriate timing of data collection; 
6. confirm that the data collection materials are sufficient; 
7. monitor the operational processes; and 
8. formalize the protocols for Nordic pole walking exercise prescription. 
See the chart in ATTACHMENT 9 for further explanations and a more detailed list of 
feasibility measurements. Notes regarding the study process will be documented throughout the 
study. Participants upon study completion will also complete a program evaluation survey 
(ATTACHMENT 10) to reflect on their experience.  
5.5.2 Participant Characteristics: Participant demographics (ATTACHMENT 11), general health 
history, smoking status, physical activity level (ATTACHMENT 12)(39), height, weight, girth 
measurements (bicep, chest, waist, hips and thigh), resting heart rate and oxygen saturation 
levels (ATTACHMENT 13) will be recorded to provide further understanding of the 
composition of the participant group.  
5.5.3 Physical Function: 
1) Lower body physical function will be measured using the 6MWT(40) and the 30-second (30-
s) chair stand test(41). The 6MWT has been recognized by the American Thoracic Society as 
a valid measure of submaximal functional capacity in those with pulmonary disease(40). 
This self-paced test measures the distance that an individual can walk over a 25 or 30m track 
in six minutes(40). Granger et al. estimated the minimal important difference for 

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deterioration of the 6MWT in lung cancer to be between 22m and 42m or a change of 
9.5%(42). Having a greater 6MWT distance was correlated with better function, increased 
physical activity and decreased dyspnea(42).  The 30-s chair stand test is a valid indication of 
lower body strength in the older adult population(41). The test requires participants to 
complete as many sit to stands as possible in 30 seconds(41). The 30-s chair stand test has 
been used to assess lower body strength in pulmonary fibrosis patients(43) and the COPD 
population(44). 
2) Upper body physical function will be assessed with the unsupported upper limb exercise test 
(UULEX)(45, 46) and the handgrip strength test. The UULEX is a valid incremental test that 
has been used to measure peak unsupported arm exercise capacity in the chronic lung disease 
population (45, 46). The test requires the seated participant to lift a plastic bar (0.2kg) 
through eight levels at a constant cadence of 30 beats per minute as directed by a metronome. 
Once the maximum height is reached the weight of the bar is increased by 0.5kg every 
minute to a maximum weight of 2.0 kg. The test continues until the participant experiences 
fatigue and decides to stop. The results are recorded in seconds. Handgrip strength is 
correlated with survival, weight loss, sarcopenia and quality of life characteristics in 
advanced cancer patients(47, 48). As recommended by the American Society of Hand 
Therapists grip strength will be measured using a dynamometer with the handle in the second 
position. Individuals will be seated with their shoulder adducted and elbow flexed 90o and 
their forearm in neutral. Three successive trials for both hands will be recorded. 
5.5.4 HRQoL: HRQoL has been shown to be a significant independent predictor of survival duration 
in the cancer population(49). We will assess HRQoL in NSCLC patients using the SF-36 
(ATTACHMENT 14)(50) and the Functional Assessment of Cancer Therapy – Lung (FACT-L) 
(version 3) (ATTACHMENT 15)(51).  
The SF-36 has been validated and used extensively as a measure of HRQoL(50). It 
assesses eight health concepts: 1) Limitations in physical activities because of health problems; 
2) Limitations in social activities because of health problems; 3) Limitations in usual role 
activities because of health problems; 4) bodily pain; 5) general mental health (psychological 
distress and well-being); 6) limitations in usual role activity because of emotional problems; 7) 
vitality (energy and fatigue); 8) general health perceptions. The SF-36 has been used in other 
studies to examine HRQoL in the NSCLC population(52-55).  
The FACT-L is a 44-item self-report instrument that measures quality of life using the 
following dimensions: physical well-being, emotional well-being, social well-being, functional 
well-being and disease specific concerns(51). The questionnaire begins with the FACT- General 
(FACT-G); a HRQoL questionnaire that was developed to be used with patients who have any 
form of cancer(51). It is supplemented with the Lung Cancer Subscale (LCS), which was 
designed to complement the FACT-G by obtaining related information about the symptom 
experience of people with lung cancer(51). The FACT-L has been proven to be reliable, valid, 
and sensitive to change in performance status(51). 
6.0 
Study Procedures (For a detailed flow diagram of study procedures see ATTACHMENT 16.) 
6.1.1 Randomization: Randomization of intervention and control groups will be computer 
generated(56) and administered by the research development assistant at the university, 
Danielle Dawson. Danielle will be kept at arm's length from the study to mitigate the risk of 
bias for the random allocation. Allocation will be concealed by placing the assignment within 
aluminum foil, and then in opaque envelopes. Study participants will choose and open the 
allocation envelope. 
6.1.2 Assessment: Written consent (ATTACHMENT 5) will be obtained from all participants prior to 

Elise Cunningham 
Pilot Study: Nordic Pole Walking & Lung Cancer 
Research Proposal 
 
October 2, 2015, Version 1 
  
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their enrolment in the study.  All participants will be scheduled for an initial assessment 
(approximately 1.5 hours in length) that will begin with a brief interview to complete the 
demographics questionnaire (ATTACHMENT 11) and the short form International Physical 
Activity Questionnaire (ATTACHMENT 12)(57). They will then have their height, weight, 
circumference measurements (biceps, chest, waist, hips, thigh), resting heart rate, and oxygen 
saturation levels measured (ATTACHMENT 13). Following these measurements participants 
will complete the lower and upper body physical function assessments (ATTACHMENT 13). 
Finally participants will be given the option of completing the HRQoL questionnaires 
(ATTACHMENTS 14 & 15) on site or take them home for completion over the phone.. The 
questionnaires take approximately 25 to 35 minutes in total to complete. Researchers will 
document and describe any planned exercise that participants are taking part in. After the eight-
week time period all participants will be scheduled for a follow-up assessment that will include 
all of the baseline measures (ATTACHMENT 17). Participants will also be asked to complete 
the program evaluation survey (ATTACHMENT 10) that will assist researchers in assessing the 
feasibility of the study. Both assessment sessions will be supervised by the primary investigator, 
Elise Cunningham, a Registered Kinesiologist. If the participant indicates any distress, they will 
be offered the opportunity to skip questions or withdraw and receive no further contact from the 
research team. If necessary the research team will advise the participant to seek a referral to a 
mental health professional from their own healthcare providers (e.g. family physician).  
6.1.3 Intervention: The intervention group will participate in an eight-week NPW program.  It will 
consist of one supervised group NPW session per week (approximately 1 hour in length) and 
three independent NPW sessions per week. Participants will be instructed on using the poles 
either immediately after their initial assessment or on an alternate date that is agreed upon 
(ATTACHMENT 18). They will be asked to practice for one week using the poles prior to their 
first group session to account for learning effect. Participants will then be assigned to a specific 
NPW prescription group (Group 1 - compromised (ATTACHMENT 19), Group 2 - inactive 
(ATTACHMENT 20) or Group 3 - minimally active and highly active (ATTACHMENT 21)) 
based on their IPAQ score and the observed ability level during the individual instruction 
session. Participants will be asked to follow their specific individualized NPW prescription 
throughout the study. During the group sessions the research team who have been trained in 
instructing NPW will correct technique, ensure participants are progressing according to the 
pre-determined exercise prescription and address any questions or concerns. Participants will 
receive training in exercise to mitigate minor risks and help assure their safety. Also 
participants will be instructed to closely monitor themselves and to maintain exertion to levels 
that suit their physical capacity (well below exhaustion). After consent is obtained each 
participant will be asked to provide the name and contact information of someone that they 
would like to be contacted should an emergency medical situation occur during their 
participation in the study. This information will be kept in a secure location separate from the 
data collection sheets during the assessments and Nordic pole walking sessions. Participants 
will be told to immediately report any exercise related symptoms to the research team. If there 
are adverse effects that can't be managed in collaboration with the participant and the on-site 
researchers, the Emergency Medical System will be initiated and the emergency contact that 
they have provided will be contacted. Additional supports may be utilized by participants (such 
as oxygen, tables, walls and chairs). Participants will be provided with the principal 
investigator's contact information should they have any questions or concerns about completing 
the Nordic pole walking sessions independently. Participants will be asked, but not compelled 
to engage in these unsupervised sessions. 
To promote program adherence participants will be asked to set exercise related goals 

Elise Cunningham 
Pilot Study: Nordic Pole Walking & Lung Cancer 
Research Proposal 
 
October 2, 2015, Version 1 
  
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(ATTACHMENT 22) prior to beginning the NPW program. Documentation of program 
adherence is critical to understanding treatment dose(58). Therefore each time participants 
complete a NPW session (supervised or at home) they will be asked to make an entry in a 
journal (ATTACHMENT 23) reporting distance walked, duration, and rate of perceived 
exertion. On days when participants do not complete a NPW session they will be asked record 
the reason they were not able to walk. The research team will contact participants over phone 
on a weekly basis to encourage participation as well as answer any questions or concerns that 
arise (ATTACHMENT 24). At the end of the program participants will reflect back on the goals 
they set to see how close they have come to achieving them. 
The control group will be instructed to continue their usual daily routine for eight-weeks 
and will be invited to participate in the same NPW program after this time period. 
7.0 
Statistical Analysis 
Narrative descriptions will be used to address feasibility outcomes. Descriptive statistics 
(mean, median, standard deviation) will be calculated for any numeric data. Non-parametric 
tests will be used to compare the intervention and control group due to small sample size; a 
Wilcoxon signed-rank test to see if changes occurred over time and a Mann-Whitney U test to 
see if there was difference between groups. A p-value of less than 0.05 will considered 
significant. 
8.0 
Data Management and Confidentiality 
Participants will be assigned a unique study number for the duration of the study. Only 
this number will be used on any research-related information collected about the participant 
during the course of this study, so that their identity as a participant in this study will be kept 
confidential.  Information that contains the participant’s identity will remain only with the 
Principal Investigator and/or designate. The list that matches the participant’s name to the 
unique study number that is used on the research-related information will not be removed or 
released without the participant’s consent unless required by law. 
Participant information and the data collected will be kept in separate locked cabinets 
within Dr. Mika Nonoyama’s secure office at UOIT. The locked cabinets will require different 
keys for access. Furthermore, de-identified data will be stored on the laptop of the Principal 
Investigator (Elise Cunningham), as well as one of the supervisor’s laptop (Dr. Mika Nonoyama) 
and will backed up on an encrypted USB flash drive. All computerized devices used throughout 
this study are password protected to reinforce confidentiality.  
After the data has been used for this study, it may be utilized again in a secondary use of 
data, but only in an aggregate way and never in a way in which the participant could be 
identified.  
 
9.0 
Knowledge Translation 
Our knowledge translation target audience are health providers and patients who have an 
interest in and/or actively involved in improving the effects of lung cancer. Our knowledge 
translation strategy is to provide this audience with a variety of products including: 1) web 
postings of plain language summary of results on a website designed for this study and with 
external organization (e.g. The Lung Association); 2) direct dissemination of summary of 
results (web, social media, brochures); 3) presentations and workshops at relevant clinical 
conferences (e.g. Canadian Respiratory Conference); and 4) publishing in a peer-reviewed 
publications. 
10.0 
Timeline 
 

Elise Cunningham 
Pilot Study: Nordic Pole Walking & Lung Cancer 
Research Proposal 
 
October 2, 2015, Version 1 
  
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Months (May 2015 – July 2016) 
Task 
S 
O 
N 
D 
J 
F 
M 
A 
M 
J 
J 
Committee Meetings 
 
 
X 
 
 
X 
 
 
 
 
 
Ethics Applications 
X 
X 
 
 
 
 
 
 
 
 
 
Prepare Tracking 
Sheets & Manual 
X 
X 
 
 
 
 
 
 
 
 
 
Recruit Patients 
 
 
X 
X 
X 
 
 
 
 
 
 
Training Research 
Personnel 
 
X 
X 
 
 
 
 
 
 
 
 
Data Collection 
 
 
X 
X 
X 
X 
X 
X 
 
 
 
Data Analysis 
 
 
 
 
 
 
X 
X 
X 
 
 
Write-up 
 
 
 
 
 
 
 
X 
X 
X 
 
Presentations 
 
 
 
 
 
 
 
X 
X 
 
 
Submit Thesis 
 
 
 
 
 
 
 
 
 
X 
 
Defend Thesis 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
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