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出境医 / 临床实验 / Nordic Pole Walking for Individuals With Cancer

Nordic Pole Walking for Individuals With Cancer

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Neoplasms Behavioral: Nordic pole walking Not Applicable

Detailed 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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Nordic Pole Walking for Individuals With Cancer: A Feasibility Study Assessing Physical Function and Health-Related Quality of Life
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017
Arms and Interventions
Arm Intervention/treatment
Experimental: Nordic pole walking
walking with a pair of poles customized to an individual's height and stride length
 Behavioral: Nordic pole walking
No Intervention: Control
usual daily routine and activities of daily living
Outcome Measures
Primary Outcome Measures :
  1. Feasibility (assessed by qualitative field notes) [ Time Frame: 8 weeks ]

    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.



Secondary Outcome Measures :
  1. 6-minute walk test (6MWT) [ Time Frame: 8 weeks ]
    The 6MWT is a measure of submaximal functional capacity. Average healthy norms (61 to 80 years old) range from 583m (women) to 687m (men).

  2. 30-second chair stand test [ Time Frame: 8 weeks ]
    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)

  3. Unsupported Upper Limb Exercise Test (UULEX) [ Time Frame: 8 weeks ]
    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).

  4. Hand grip strength [ Time Frame: 8 weeks ]
    average healthy norms (60 to 79 years old) ranging from 24kg (women) and 41kg

  5. Functional Assessment of Cancer Therapy-Lung (FACT-L) [ Time Frame: 8 weeks ]
    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.

  6. 36-Item Short Form Health (SF-36) Questionnaire [ Time Frame: 8 weeks ]
    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.

  7. International Physical Activity Questionnaire (IPAQ) [ Time Frame: 8 weeks ]
    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)


Other Outcome Measures:
  1. Demographic information [ Time Frame: baseline ]
    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.

  2. Resting heart rate [ Time Frame: baseline and 8 weeks ]
    beats per minute

  3. Oxygen saturation [ Time Frame: baseline and 8 weeks ]
    in %

  4. Height [ Time Frame: baseline and 8 weeks ]
    meters

  5. Weight [ Time Frame: baseline and 8 weeks ]
    meters

  6. Body mass index [ Time Frame: baseline and 8 weeks ]
    calculated as height divided by weight squared

  7. Bicep circumferences [ Time Frame: baseline and 8 weeks ]
    cm

  8. Chest circumference [ Time Frame: baseline and 8 weeks ]
    cm

  9. Waist circumference [ Time Frame: baseline and 8 weeks ]
    cm

  10. Hip circumference [ Time Frame: baseline and 8 weeks ]
    cm

  11. Thigh circumferences [ Time Frame: baseline and 8 weeks ]
    cm


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE April 26, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date May 8, 2019
Actual Study Start Date  ICMJE December 16, 2015
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019) 		Feasibility (assessed by qualitative field notes) [ Time Frame: 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • 6-minute walk test (6MWT) [ Time Frame: 8 weeks ]
    The 6MWT is a measure of submaximal functional capacity. Average healthy norms (61 to 80 years old) range from 583m (women) to 687m (men).
  • 30-second chair stand test [ Time Frame: 8 weeks ]
    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)
  • Unsupported Upper Limb Exercise Test (UULEX) [ Time Frame: 8 weeks ]
    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).
  • Hand grip strength [ Time Frame: 8 weeks ]
    average healthy norms (60 to 79 years old) ranging from 24kg (women) and 41kg
  • Functional Assessment of Cancer Therapy-Lung (FACT-L) [ Time Frame: 8 weeks ]
    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.
  • 36-Item Short Form Health (SF-36) Questionnaire [ Time Frame: 8 weeks ]
    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.
  • International Physical Activity Questionnaire (IPAQ) [ Time Frame: 8 weeks ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 6, 2019)
  • Demographic information [ Time Frame: baseline ]
    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.
  • Resting heart rate [ Time Frame: baseline and 8 weeks ]
    beats per minute
  • Oxygen saturation [ Time Frame: baseline and 8 weeks ]
    in %
  • Height [ Time Frame: baseline and 8 weeks ]
    meters
  • Weight [ Time Frame: baseline and 8 weeks ]
    meters
  • Body mass index [ Time Frame: baseline and 8 weeks ]
    calculated as height divided by weight squared
  • Bicep circumferences [ Time Frame: baseline and 8 weeks ]
    cm
  • Chest circumference [ Time Frame: baseline and 8 weeks ]
    cm
  • Waist circumference [ Time Frame: baseline and 8 weeks ]
    cm
  • Hip circumference [ Time Frame: baseline and 8 weeks ]
    cm
  • Thigh circumferences [ Time Frame: baseline and 8 weeks ]
    cm
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Nordic Pole Walking for Individuals With Cancer
Official Title  ICMJE Nordic Pole Walking for Individuals With Cancer: A Feasibility Study Assessing Physical Function and Health-Related Quality of Life
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer
  • Neoplasms
Intervention  ICMJE Behavioral: Nordic pole walking
Study Arms  ICMJE
  • Experimental: Nordic pole walking
    walking with a pair of poles customized to an individual's height and stride length
    Intervention: Behavioral: Nordic pole walking
  • No Intervention: Control
    usual daily routine and activities of daily living
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2019) 		8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03942614
Other Study ID Numbers  ICMJE 15-018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Sharing upon request.
Responsible Party Mika Nonoyama, University of Ontario Institute of Technology
Study Sponsor  ICMJE University of Ontario Institute of Technology
Collaborators  ICMJE
  • Lakeridge Health Corporation
  • Southlake Regional Health Centre
Investigators  ICMJE Not Provided
PRS Account University of Ontario Institute of Technology
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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