Comparison of AT & PR Training to Improve Functional Abil... | NCT05873036

Studies
Comparison of AT & PR Training to Improve Functional Ability After Breast Cancer Surgery

NCT05873036

Sponsor

Superior University

Status

Unknown status

Last Update Posted

May 24, 2023Actual

Enrollment

74Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Aerobic Training
Progressive Resistance Training

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Aug 31, 2023Estimated

First Submitted Date

Mar 18, 2023

First Submission Date that Met QC Criteria

May 23, 2023

First Posted Date

May 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2023

Last Update Posted Date

May 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aerobic Training	Other		Diagnostic Test: Aerobic Training
Progressive Resistance Training	Experimental		Diagnostic Test: Progressive Resistance Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aerobic Training	Diagnostic Test	Aerobic Training to Improve Functional Ability After Breast Cancer Surgery	Aerobic Training

Measure	Description	Time Frame
Numerical pain rating scale (NPRS)		6 Months
Goniometer Tool		6 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shama Zahid, DPT	Contact	+923134432808		dptm-f18-172@superior.edu.pk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chaudhary Muhammad Akram Teaching and research hospital, Jinnah Hospital Lahore and Mayo Hospital Lahore	Recruiting	Lahore	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided