NCT03942614

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Dec 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

April 26, 2019

Last Update Submit

May 6, 2019

Conditions

Keywords

Nordic Pole WalkingExerciseRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 6-minute walk test (6MWT)

    8 weeks

  • 30-second chair stand test

    8 weeks

  • Unsupported Upper Limb Exercise Test (UULEX)

    8 weeks

  • Hand grip strength

    8 weeks

  • Functional Assessment of Cancer Therapy-Lung (FACT-L)

    8 weeks

  • +2 more secondary outcomes

Other Outcomes (11)

  • Demographic information

    baseline

  • Resting heart rate

    baseline and 8 weeks

  • Oxygen saturation

    baseline and 8 weeks

  • +8 more other outcomes

Study Arms (2)

Nordic pole walking

EXPERIMENTAL

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

Behavioral: Nordic pole walking

Control

NO INTERVENTION

usual daily routine and activities of daily living

Interventions

Nordic pole walking

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • engaged in NPW within the last six-months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

WalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2019

First Posted

May 8, 2019

Study Start

December 16, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 8, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Sharing upon request.