NCT05873036

Brief Summary

To determine the effect of aerobic training and progressive resistance training to improve upper limb functional ability after breast cancer surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

March 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

March 18, 2023

Last Update Submit

May 23, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Numerical pain rating scale (NPRS)

    6 Months

  • Goniometer Tool

    6 Months

Study Arms (2)

Aerobic Training

OTHER
Diagnostic Test: Aerobic Training

Progressive Resistance Training

EXPERIMENTAL
Diagnostic Test: Progressive Resistance Training

Interventions

Aerobic TrainingDIAGNOSTIC_TEST

Aerobic Training to Improve Functional Ability After Breast Cancer Surgery

Aerobic Training

Progressive Resistance Training to Improve Functional Ability After Breast Cancer Surgery

Progressive Resistance Training

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a) Breast cancer female survivors eligible under 35-65 years complaining of cancer-related fatigue.
  • b) Adjunctive radiotherapy or underwent surgery (lumpectomy or mastectomy), willing to participate will be included in the study.
  • c) Shoulder pain d) Decreased ROM e) Primary unilateral BC, ALND, no distant metastases, no previous ALND on the contra lateral side f) No previous history of arm lymph edema

You may not qualify if:

  • \- a) Survivors with other concurrent metastasis anywhere else in the body, diagnosed case of any cardiac or respiratory condition, contra-indicated for exercise training (severe dyspnea, chest pain, severe nausea, ataxia, dizziness etc.) b) Any other neurological or recent musculoskeletal problems were excluded from the study.
  • c) Bilateral mastectomy d) Adjunctive chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaudhary Muhammad Akram Teaching and research hospital, Jinnah Hospital Lahore and Mayo Hospital Lahore

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2023

First Posted

May 24, 2023

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

August 31, 2023

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations