NCT07070791

Brief Summary

According to updated data from the International Agency for Research on Cancer (IARC) for 2022, breast cancer in women is responsible for one in four cancer cases and one in six cancer deaths worldwide and is the second leading cause of global cancer incidence, accounting for 11.6% of all cancer cases, and the fourth leading cause of cancer deaths worldwide, accounting for 6.9% of all cancer deaths. During or after breast cancer treatments, there is exposure to a variety of direct (local/regional treatment, systemic treatment and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that may have adverse effects on treatment-related haematological, cardiovascular, pulmonary and musculoskeletal components. Upper limb dysfunction and lymphoedema have been reported to be two of the most common side effects affecting the quality of life of breast cancer patients after breast cancer treatments. The elastic resistance band, which is widely used in strength training, has the advantage of being applied to various classes because it provides resistance angles in various postures and has a low risk of injury. However, few studies have been conducted on elastic resistance band application in patients with breast cancer. At the same time, evidence on the effectiveness of upper extremity aerobic exercise training in patients with breast cancer is limited. Therefore, this study aimed to investigate the effects of upper extremity aerobic exercise training combined with progressive resistance training and upper extremity aerobic exercise training alone on upper extremity exercise capacity, upper extremity functionality, sarcopenia, frailty, quality of life and lymphedema in patients with breast cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
2mo left

Started Jul 2025

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress85%
Jul 2025Jul 2026

Study Start

First participant enrolled

July 8, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

July 9, 2025

Last Update Submit

December 25, 2025

Conditions

Keywords

breast cancerUpper Extremityresistance exercise trainingAerobic exercise training

Outcome Measures

Primary Outcomes (2)

  • 6 minute Pegboard and Ring Test - 6PBRT

    Total number of rings inserted in six minutes

    One Year

  • Maximal Arm Exercise Capacity

    VO2peak requirement during arm ergometry will be estimated using MET levels calculated at each power output based on gender at various body weights and will be displayed in ml/kg/min (1 MET = 3.5 ml/kg/min)

    One Year

Secondary Outcomes (9)

  • Evaluation of Quality of Life

    One Year

  • Peripheral Muscle Strength

    One Year

  • Anthropometric Measurements

    One Year

  • Comorbidity Assessment

    One Year

  • Peripheral muscle strength assessment

    One Year

  • +4 more secondary outcomes

Study Arms (2)

Upper Extremity Aerobic Exercise

ACTIVE COMPARATOR

Participants will only receive a 12-week upper limb aerobic exercise training program.

Other: Upper Extremity Aerobic Exercise Training

Upper Extremity Progressive Resistance Training Combined with Aerobic Exercise Training

EXPERIMENTAL

Participants will receive a 12-week upper extremity aerobic exercise training program plus upper extremity progressive resistance exercise training.

Other: Upper Extremity Aerobic Exercise TrainingOther: Upper Extremity Progressive Resistance Exercise Training

Interventions

Upper extremity progressive resistance training was gradually increased over 12 weeks using elastic resistance bands.

Upper Extremity Progressive Resistance Training Combined with Aerobic Exercise Training

12 weeks of upper extremity aerobic exercise training, 3 sessions per week, 25 minutes per session.

Upper Extremity Aerobic ExerciseUpper Extremity Progressive Resistance Training Combined with Aerobic Exercise Training

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be between 18-80 years old,
  • Volunteering to participate in the research,
  • At least 15 months after breast cancer surgery,
  • No problems in reading and/or understanding the scales and being able to co-operate with the tests.
  • Physically inactive (60 minutes of structured exercise per week \<).

You may not qualify if:

  • Presence of active infection,
  • Presence of bilateral breast cancer,
  • History of surgical, neurological or orthopaedic problems that may affect upper extremity functionality other than breast cancer surgery,
  • Having a neurological disease or other clinical diagnosis that may affect cognitive status,
  • Musculoskeletal and neurological disease that may affect exercise performance, symptomatic heart disease, previous lung surgery and malignant disease.
  • Presence of unstable hypertension or diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hcettepe University

Ankara, State, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Melda Saglam, PhD

    Hacettepe University

    STUDY CHAIR
  • Ebru Calik Kutukcu, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebru Calik Kutukcu, PhD

CONTACT

Naciye Vardar-Yagli, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study consisted of two groups: one group performed upper extremity aerobic exercise while the other group performed both upper extremity aerobic exercise and upper extremity progressive resistance training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 17, 2025

Study Start

July 8, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations