Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors

NCT03539835 | Completed DMC

• 1 other identifier: IRB00103558
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study will begin to fill a knowledge gap by determine whether changes in kynurenine metabolism occur following Resistance Training (RT) and relate to reductions in inflammation and improved behavioral and physical function as this may identify potential targets for interventions to promote cancer recovery.

Conditions

Cancer

Keywords

Breast Cancer Survivors; Resistance Training; Fatigue; Physical Function; Behavioral Function; Kynurenine metabolism

Outcome Measures

Primary Outcomes (1)

• Change in fatigue assessed by Multidimensional Fatigue Inventory (MFI) score

  The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each scale contains four items for which the person had to indicate on a seven-point scale to what extent the particular statement applies to him or her. An equal number of items is worded in a positive and in a negative direction to counteract response tendencies.

  Baseline, 12 weeks follow up

Secondary Outcomes (14)

• Change in depression assessed by Hamilton Depression Rating Scale (HAM-D) score

  Baseline, 12 weeks follow up

• Change in balance test score

  Baseline, 12 weeks follow up

• Change in muscle function assessed by Isometric Handgrip test.

  Baseline, 12 weeks follow up

• Change in muscle function assessed by Lower Extremity Endurance test

  Baseline, 12 weeks follow up

• Change in muscle function assessed by Lower Extremity Strength test

  Baseline, 12 weeks follow up

Study Arms (2)

Resistance training

EXPERIMENTAL

Other: Resistance training (RT)

Cognitively-based compassion training

ACTIVE COMPARATOR

Behavioral: Cognitively-based compassion training control (CBCT)

Interventions

Resistance training (RT) OTHER

Resistance training (RT) will include 15 repetitions for two sets and to exhaustion on the third set for seven major muscle groups: the leg and chest press, knee extension, leg curl, row, abdominal crunch, and bicep curl. Resistance is gradually increased to account for strength gains when subjects are able to complete 20 repetitions on the third set.

Resistance training

Cognitively-based compassion training control (CBCT) BEHAVIORAL

Cognitively-based compassion training control (CBCT) classes will be performed in a group setting for 1.5-2 hours per week, and consist of didactics, class discussion, and guided meditation practice. Each class will begin with a period of meditation to calm and focus the mind, followed by analytical practices designed to challenge unexamined assumptions regarding feelings, and actions toward others with a focus on generating spontaneous empathy and compassion for themselves and others.

Cognitively-based compassion training

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• within 6 months to 10 years post active breast cancer therapy (i.e. surgery/chemotherapy) for stage I-III invasive breast cancer,
• at least 6 months post breast reconstruction (if applicable),
• lack of menses for at least one year,
• BMI 20-35 kg/m2,
• fatigued (subjective reporting ≥3 on a 1-10 scale),
• untrained with regard to structured resistance training (no more than 3x/week).

You may not qualify if:

• plans for surgery (e.g., breast reconstruction) during the study period,
• taking an anticoagulant medication (i.e. heparin, apixaban, rivaroxaban),
• allergic to lidocaine,
• orthopedic or chronic pain condition restricting exercise,
• Mini-Mental Status Examination (MMSE) scores below education-specific cut-points (less than 23 for more than 9th grade education and less than 17 for less than 8th grade education),
• unable to receive physician medical clearance.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Neoplasms; Fatigue

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Monica Serra, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: December 10, 2018
• Primary Completion: March 9, 2020
• Study Completion: March 12, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)