Nordic Pole Walking for Individuals With Cancer

Cancer Clinical Trial

Official title:

Nordic Pole Walking for Individuals With Cancer: A Feasibility Study Assessing Physical Function and Health-Related Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942614
• Other study ID #: 15-018
• Status: Completed
• Phase: N/A
• Start date: December 16, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2019
• Source: University of Ontario Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Individuals diagnosed with cancer tend to be inactive and have symptom burdens that impact quality of life. A community-based Nordic Pole Walking (NPW) program may help. The primary objective of this study was to see if it was feasible to do to a larger trial. The secondary objective was to determine the effects of NPW on physical function and health-related quality of life (HRQoL). NPW or no NPW was randomly assigned to adults with non-small cell lung, prostate, colorectal, and endometrial. Eight people were enrolled in the study with 4 in the NPW group (1 dropped out) and 4 in the no NPW group.

Description:

Individuals diagnosed with cancer tend to be inactive and have symptom burdens that impact quality of life. An individualized, community-based Nordic pole walking (NPW) program may help. The primary objective of this study was to assess feasibility using the Thabane Framework of a randomized controlled trial (RCT). The secondary objective was to determine the effects of NPW on physical function (six-minute walk test, 30-second [30-s] chair stand test, Unsupported Upper Limb Exercise Test, handgrip strength, physical activity [PA]), and health-related quality of life (HRQoL, 36-Item Short Form Health [SF-36]). The study design was an eight-week multi-centred block randomized controlled feasibility study (no blinding) comparing a NPW program (versus usual daily routine) for adults with non-small cell lung, prostate, colorectal, and endometrial cancer, from hospitals and cancer support groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• a primary diagnosis (including reoccurrence) of histologically confirmed stage I-IV NSCLC, prostate, colorectal, or endometrial cancer (with any concurrent cancer treatment)

• a cancer diagnosis or treatment within the last three years

• = 55 years old

• approval by the primary treating physician

• ability to communicate in English.

Exclusion Criteria:

• engaged in NPW within the last six-months

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Intervention

Behavioral:
• Nordic pole walking

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Ontario Institute of Technology	Lakeridge Health Corporation, Southlake Regional Health Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic information	A data collection form was used to collect demographic information including cancer diagnosis and treatments, side effects, general health history, and smoking status (baseline only). No formal scale was used to collect this information; only descriptive information was collected.	baseline
Other	Resting heart rate	beats per minute	baseline and 8 weeks
Other	Oxygen saturation	in %	baseline and 8 weeks
Other	Height	meters	baseline and 8 weeks
Other	Weight	meters	baseline and 8 weeks
Other	Body mass index	calculated as height divided by weight squared	baseline and 8 weeks
Other	Bicep circumferences	cm	baseline and 8 weeks
Other	Chest circumference	cm	baseline and 8 weeks
Other	Waist circumference	cm	baseline and 8 weeks
Other	Hip circumference	cm	baseline and 8 weeks
Other	Thigh circumferences	cm	baseline and 8 weeks
Primary	Feasibility (assessed by qualitative field notes)	Feasibility was assessed using the framework as described by: Thabane L et al (2010) A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology, vol 10. England, p 1.; The Thabane Framework uses 4 criteria to measure feasibility: Process, Resources, Management and Scientific. For each criteria, detailed field notes regarding objectives and measures were maintained throughout the study. These notes on the four Thabane criteria were used to categorize the study to one of four possible outcomes: 1) stop - the study is not feasible; 2) continue, but modify the protocol - the study is feasible with modifications; 3) continue without modifications, but monitor closely - the study is feasible with close monitoring; and 4) continue without modifications - the study is feasible as is.	8 weeks
Secondary	6-minute walk test (6MWT)	The 6MWT is a measure of submaximal functional capacity. Average healthy norms (61 to 80 years old) range from 583m (women) to 687m (men).	8 weeks
Secondary	30-second chair stand test	The 30-s chair stand test is a measure of lower body strength. In 60 to 94 years olds, average healthy norms range from 13 (women) to 14 (men)	8 weeks
Secondary	Unsupported Upper Limb Exercise Test (UULEX)	UULEX, an incremental test that measures peak unsupported arm exercise capacity. UULEX average healthy norms (40 to 89 years old) range from 11 (women) to 12 minutes (men).	8 weeks
Secondary	Hand grip strength	average healthy norms (60 to 79 years old) ranging from 24kg (women) and 41kg	8 weeks
Secondary	Functional Assessment of Cancer Therapy-Lung (FACT-L)	The FACT-L is a measure of health-related quality of life and includes 4 general and 1 lung cancer symptom-specific domain. The general domains (27 questions) include: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), and functional well-being (FWB). The lung cancer symptom specific (LCS) domain (7 questions) evaluates symptoms that are commonly experienced by lung cancer patients (i.e. shortness of breath, weight loss, and chest tightness). Domain scores are then combined to calculate the Total Outcome Index (TOI) (TOI = PWB + FWB + LCS), Functional Assessment of Cancer Therapy - General (FACT-G) score (FACT G = PWB + SWB + EWB + FWB), and FACT-L score (FACT-L = FACT- G + LCS). TOI range 0 to 135 with higher score better quality of life.	8 weeks
Secondary	36-Item Short Form Health (SF-36) Questionnaire	The SF-36 is a measure of generic health-related quality of life. It assesses 8 health concepts (scales): 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health; 6) limitations in usual role activities because of emotional problems; 7) vitality; and 8) general health perceptions. Scoring is a two-step process. First, precoded numeric values are recoded per a scoring key. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores (quality of life) are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. More information: https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html.	8 weeks
Secondary	International Physical Activity Questionnaire (IPAQ)	The IPAQ is a measure physical activity level. Questions ask about walking, moderate-intensity activities, vigorous-intensity activities, and sitting during the following 4 domains: a) leisure time physical activity; b) domestic and gardening activities; c) work-related physical activity; and d) transport-related physical activity. Two types of scoring were done: 1) in categories (low activity levels, moderate activity levels or high activity levels), and 2) as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity and is a multiple of a person's estimated resting energy expenditure. One MET is what is expended when at rest. To get MET minutes a week from the IPAQ walking was considered 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity 8 METS. (reference: https://ugc.futurelearn.com/uploads/files/bc/c5/bcc53b14-ec1e-4d90-88e3-1568682f32ae/IPAQ_PDF.pdf)	8 weeks