NCT03650322

Brief Summary

The investigators propose to compare the effects of a 12-week, supervised, site-based group yoga intervention on cognitive function, functional fitness, and well-being in middle-aged cancer survivors. Subjects will be randomly assigned to one of three exercise conditions: a yoga group, an aerobic walking group or a strength training group. All sessions (2-3 times per week) will be led by a trained exercise leader for a total of 150 minutes of exercise each week for the 12-week intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Oct 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

August 22, 2018

Last Update Submit

June 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive Function

    Participants will complete part of the NIH Toolbox measures that assess cognitive function.

    Change from baseline to 12 weeks will be reported

Secondary Outcomes (1)

  • Cardiovascular Function

    Change from baseline to 12 weeks will be reported

Other Outcomes (1)

  • Feasibility: Recruitment and retention rates

    Baseline to 12-weeks

Study Arms (3)

Yoga Practice

EXPERIMENTAL

Participants will be led through a beginner yoga course taught by a certified yoga instructor. Classes will meet twice a week for 75 minutes each for the duration of 12 weeks. Sessions will focus on yoga postures, breathing, and meditative practices and may utilize mats, blocks, belts, and blankets.

Behavioral: Yoga

Stretching and Toning

ACTIVE COMPARATOR

This 12 week, progressive stretching and toning course will aid participants in building whole body strength and flexibility by utilizing weights, chairs, mats, and various other exercise equipment. Sessions will meet three times a week for 50 minutes and will offer 'easy' and 'hard' modifications taught by an exercise leader.

Behavioral: Stretching and Toning

Aerobic Walking

EXPERIMENTAL

Participants will partake in treadmill walking that encourages them to reach a pre-determined heart rate range. Sessions will be conducted three times a week for 50 minutes, and offer participants to self-select a speed and incline to meet their target heart rate zone.

Behavioral: Aerobic Walking

Interventions

YogaBEHAVIORAL

12 weeks, total of 150 minutes of exercise per week.

Yoga Practice

12 weeks, total of 150 minutes of exercise per week.

Stretching and Toning
Aerobic WalkingBEHAVIORAL

12 weeks, total of 150 minutes of exercise per week.

Aerobic Walking

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Cancer diagnosis
  • year since last cancer treatment (surgery, chemotherapy, and/or radiation)
  • Not planning to receive treatment during study period
  • Completion of Physical Activity Readiness Questionnaire (PAR-Q)
  • Ambulatory and absence of health conditions that may be exacerbated by yoga, walking, or strength training
  • Physician consent (if deemed necessary)
  • Low-active, i.e. less than 150 minutes/week of moderate to vigorous exercise, no current yoga practice (including within last six months)
  • Intention to remain in the Champaign-Urbana area over the study duration
  • Willingness to be randomly assigned to one of the three groups (yoga, aerobic walking, strength training)
  • Comfortable with reading, writing, and speaking English

You may not qualify if:

  • Below 30 or above 70 years of age
  • Cancer diagnosis of the brain
  • Less than 1 year since last treatment (surgery, chemotherapy, and/or radiation) or plans to receive treatment during study
  • Determined ambulatory or 'high risk' based on responses to PAR-Q
  • High-active (exercising more than 150 minutes/week in the last six months)
  • No consent from physician
  • Intent to be away from the Champaign-Urbana area for an extended period of time during the study
  • Inability to communicate effectively in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • Gothe NP, Erlenbach ED, Streeter SL, Lehovec L. Effects of yoga, aerobic, and stretching and toning exercises on cognition in adult cancer survivors: protocol of the STAY Fit pilot randomized controlled trial. Trials. 2020 Sep 15;21(1):792. doi: 10.1186/s13063-020-04723-2.

Related Links

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

Yoga

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Neha Gothe, Ph.D., M.A.

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 28, 2018

Study Start

October 1, 2018

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

July 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations