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Clinical Trials/NCT02465541
NCT02465541
Completed
Not Applicable

Lifestyle Interventions to Improve Physical Function and Quality of Life in Endometrial Cancer Survivors: The Role of a Gentle Yoga Based Exercise Program

Ohio State University Comprehensive Cancer Center1 site in 1 country16 target enrollmentJuly 23, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Ohio State University Comprehensive Cancer Center
Enrollment
16
Locations
1
Primary Endpoint
Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB).
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This randomized clinical trial studies how well gentle yoga and dietary counseling lifestyle change effects physical function and quality of life of endometrial cancer survivors. Gentle yoga and dietary counseling may help improve physical function and quality of life for stage I-II endometrial cancer survivors.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the feasibility and efficacy of a combined lifestyle intervention (yoga + diet) to positively impact physical function and quality of life for endometrial cancer survivors. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Participants undergo onsite gentle yoga once weekly over 45-60 minutes for 8 weeks and home-based gentle yoga for 6 weeks. Participants also undergo dietary counseling over 8 weeks. ARM II: Participants undergo enhanced usual care designed to educate on best practices for exercise, diet and lifestyle change once weekly for 14 weeks.

Registry
clinicaltrials.gov
Start Date
July 23, 2013
End Date
April 27, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brian Focht

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

Inclusion Criteria

  • English speaking
  • Previous diagnosis of grade 1 or 2, stage I or II endometrioid endometrial cancers ("type I cancers") as confirmed during surgical intervention for treatment
  • Overweight or obese (\> 25 kg/m\^2)
  • Anytime from treatment
  • Treating oncologist consent
  • Primary physician consent to engage in physical activity unsupervised
  • Ambulatory or able to engage in walking for at least 15 minutes
  • Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week

Exclusion Criteria

  • No prior type I endometrial cancer diagnosis
  • Prior diagnosis of other cancer
  • Currently (previous 6 months) engaged in structured exercise either aerobic or yoga based
  • Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension
  • Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician
  • Non-ambulatory
  • Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
  • Major mental illness (e.g., schizophrenia, major depressive disorder)
  • Unwilling to give consent

Outcomes

Primary Outcomes

Examine change from baseline in physical function as measured by the Short Physical Performance Battery (SPPB).

Time Frame: Up to 14 weeks

Physical function will be assess using a SPPB walk performance assessment. Quality life will be assessed via the SF-36 and the Functional Assessment of Cancer Therapy-Endometrial FACT-EN.

Secondary Outcomes

  • Examine intervention feasibility using a composite assessment.(Up to 14 weeks)

Study Sites (1)

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