NCT03084692

Brief Summary

The purpose of the study is to determine the feasibility and preliminary efficacy of a combined therapeutic yoga and resistance exercise intervention for individuals with lung cancer and their caregivers. The investigators aim is to help reduce the fear of exercise by tailoring the program to meet the specific needs of the survivor with lung cancer. The investigators want to see whether individuals with lung cancer and their caregivers are interested in participating in this type of program, and if they are able to attend the intervention sessions and complete the program. The investigators also plan to study the preliminary effects of therapeutic yoga and resistance exercise on fitness outcomes for both individuals with lung cancer and their caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

April 14, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

October 15, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

March 14, 2017

Last Update Submit

October 12, 2018

Conditions

Lung Cancer

Keywords

caregiverlung canceryogaresistance exercise

Outcome Measures

Primary Outcomes (1)

  • Completion Rate

    Completion rate is defined as the number of participants successfully completing the baseline assessment, intervention, and the post-intervention assessment.

    Up to 24 weeks

Secondary Outcomes (12)

  • Dyspnoea Visual Analogue Scale

    8 weeks

  • Dyspnoea-12

    8 weeks

  • Functional Assessment of Cancer Therapy: Fatigue Scale (FACT-F)

    8 weeks

  • Chest expansion (centimetres)

    8 weeks

  • Shoulder Range of Motion (degrees)

    8 weeks

  • +7 more secondary outcomes

Study Arms (1)

Therapeutic Yoga and Resistance Exercise

EXPERIMENTAL

The individuals with lung cancer and their caregivers will participate in a combined intervention of yoga and resistance exercise for 8-week, two times/week. The dyad will attend a one-hour resistance exercise intervention at the start of the week and a one-hour yoga class with a break of one day between both interventions. The resistance exercise training will involve one-on-one personal exercise session, while the yoga intervention will be offered in a class setting. The participants will be allowed to make up for any missed resistance exercise session based on the available time. Pamphlets will be given demonstrating breathing exercises, meditation, postures, and core resistance exercises to facilitate programming.

Behavioral: Therapeutic Yoga and Resistance Exercise

Interventions

Therapeutic Yoga and Resistance ExerciseBEHAVIORAL

Combined Program of Yoga and Resistance Exercise

Therapeutic Yoga and Resistance Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Primary Lung Cancer Stage I-IV (all stages)
  • Any form of Lung cancer included: Small Cell Lung Cancer and Non-Small Cell Lung Cancer
  • Age: 18 years or above
  • Patients at any time point during treatment: ongoing treatment, completed treatment or recently diagnosed and about to start treatment
  • Karnofsky Performance Status ≥ 50 (Appendix A)
  • Life expectancy at least one year -

You may not qualify if:

  • Metastatic lung disease that would preclude safe exercise prescription
  • Secondary Lung cancer due to metastasis from other parts of body
  • Co-morbid conditions such as diabetes, congestive heart failure, dementia, cerebrovascular diseases.
  • Individuals who would be unsafe to participate in an intervention program.
  • Unable to provide consent in English
  • Unable to complete either testing or intervention components (e.g. extended holiday)
  • Caregiver eligibility: Caregivers will be screened using the PAR-Q + questionnaire and will be required to obtain approval from a family physician should any safety concerns be identified.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, T6G 2G4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Margaret McNeely

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: A single group before and after intervention study design will be used for this pilot feasibility trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 21, 2017

Study Start

April 14, 2017

Primary Completion

May 30, 2018

Study Completion

May 31, 2018

Last Updated

October 15, 2018

Record last verified: 2018-04

Locations

CA(1)