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临床试验/NCT03942614
NCT03942614已完成不适用

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

University of Ontario Institute of Technology0 个研究点目标入组 8 人开始时间: 2015年12月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
主要终点
Feasibility (assessed by qualitative field notes)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • engaged in NPW within the last six-months

研究组 & 干预措施

Nordic pole walking

Experimental

walking with a pair of poles customized to an individual's height and stride length

干预措施: Nordic pole walking (Behavioral)

Control

No Intervention

usual daily routine and activities of daily living

结局指标

主要结局

Feasibility (assessed by qualitative field notes)

时间窗: 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.

次要结局

  • Unsupported Upper Limb Exercise Test (UULEX)(8 weeks)
  • 36-Item Short Form Health (SF-36) Questionnaire(8 weeks)
  • Hand grip strength(8 weeks)
  • International Physical Activity Questionnaire (IPAQ)(8 weeks)
  • 6-minute walk test (6MWT)(8 weeks)
  • 30-second chair stand test(8 weeks)
  • Functional Assessment of Cancer Therapy-Lung (FACT-L)(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mika Nonoyama

Assistant Professor

University of Ontario Institute of Technology

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