NCT05720858

Brief Summary

The aim of this study is to determine the effect of telerehabilitation-based aerobic exercises on upper extremity functionality, cognitive status and quality of life in patients with survival breast cancer.

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
69

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2022

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

Study Start

First participant enrolled

October 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 27, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 9, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

November 27, 2022

Last Update Submit

January 31, 2023

Conditions

Breast CancerTelerehabilitationExerciseSurvival

Outcome Measures

Primary Outcomes (3)

  • EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)

    The EORTC-QLQ-C30 Quality of Life Scale includes 30 questions and three subheadings: general well-being, functional difficulties, and symptom control. The first 28 of the 30 items in the scale are a four-point Likert-type scale and the items are evaluated as Never: 1, A little: 2, Quite: 3 or A lot: 4 points. In the 29th question of the scale, the patient is asked to evaluate his health on a scale from 1 to 7 (1: Very poor and 7: Excellent), and in the 30th question, the general quality of life. The 29th and 30th questions constitute the general well-being area. High scores in this section indicate a high quality of life, and low scores indicate a decrease in quality of life. (Hospital group, telerehabilitation group and control group will be evaluated)

    A day before the treatment

  • Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)

    This form evaluates the parameters of cognitive sensitivity (sharpness), attention and coordination, memory, verbal fluency, functional confusion, observations of others about the individual, change in functionality compared to before, and quality of life. It consists of 4 subtitles and 37 questions in total. Questions in the sections of perceived cognitive impairment, comments from other people, perceived cognitive skills, and impact on quality of life are scored between 0 and 4 (0-several times per day times, 4-never). In 9 questions in the field of perceived cognitive skills, the score calculation is evaluated as 0-none, 4-too much. Perceived cognitive disorders and perceived cognitive skills subsections contain opposite questions and the last 2 questions are not included in the scoring. The increase in the total score indicates the goodness of the situation in terms of cognitive functions.(Hospital group, telerehabilitation group and control group will be evaluated)

    A day before the treatment

  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

    The Arm, Shoulder and Hand Injuries Questionnaire (DASH) will be used to evaluate the functions of the upper extremities.This questionnaire assesses disability, activity limitations, restriction on leisure activities and participation in work. The DASH questionnaire consists of three parts. The first part consists of 30 questions. 21 questions determine the patient's difficulty during activities of daily living, five questions determine the symptoms (pain, activity-related pain, tingling, stiffness, weakness), each of the remaining four questions determine the social function, work, sleep and the patient's function /symptom score.(Hospital group, telerehabilitation group and control group will be evaluated)

    A day before the treatment

Secondary Outcomes (4)

  • Chronic Disease Treatment Functional Assessment Fatigue (FACIT Fatigue) Scale

    Baseline, 6 weeks, 12 weeks, and 6 months

  • EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)

    6 weeks, 12 weeks, and 6 months

  • Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)

    6 weeks, 12 weeks, and 6 months

  • Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

    6 weeks, 12 weeks, and 6 months

Study Arms (3)

Hospital group

EXPERIMENTAL

A total of 36 sessions (3 days a week) will be applied. Training intensity will be performed at the level of 4-6 according to the modified Borg scale, and rest will be allowed between exercises according to the tolerance of the patients. In the hospital-based group, a supervised aerobic exercise program will be applied in the hospital. There will be warm-up exercises before the exercise and cool-down exercises after. At the beginning of the session, warm-up exercises will begin. Flexibility exercises will be applied during the warm-up period. Warm-up and cool-down exercises will be performed for 10 minutes with 3 repetitions, including the upper and lower extremities and distal joints. Exercises will be performed for 3 months, with 10 repetitions in the first 6 weeks and 15 repetitions in the next 6 weeks.

Other: Aerobic exercise

Telerehabilitation group

EXPERIMENTAL

A total of 36 sessions (3 days a week) will be applied. Training intensity will be performed at the level of 4-6 according to the modified Borg scale, and rest will be allowed between exercises according to the tolerance of the patients. Supervised sessions will be held with the telerehabilitation group via phone or computer video conference (For patients who agree to participate, the physiotherapist will initially conduct the first session face-to-face). There will be warm-up exercises before the exercise and cool-down exercises after. At the beginning of the session, warm-up exercises will begin. Flexibility exercises will be applied during the warm-up period. Warm-up and cool-down exercises will be performed for 10 minutes with 3 repetitions, including the upper and lower extremities and distal joints. Exercises will be performed for 3 months, with 10 repetitions in the first 6 weeks and 15 repetitions in the next 6 weeks.

Other: Aerobic exercise

Control group

NO INTERVENTION

They will continue their routine activities. After the study, those who wish will be included in the exercise program.

Interventions

Aerobic exerciseOTHER

Reciprocal straight leg lift, Reciprocal hip knee flexion-extension, Lateral spinal rotation (Spinal rotation), Bridge Exercise, Elbow winging, Hip abduction, trunk extension, Shoulder elevation, Shoulder circulation, Shoulder flexion and extension, Shoulder abduction adduction, Reciprocal lateral trunk flexion and extension, Puching exercise, Mini Squat exercise, Reaching upward with hands reciprocally, Scapular adduction (Hands at waist), Push-ups on the wall, Knee Touch exercise, Arm Circles exercise, Reaching for feet in sitting position, Saw (The saw) exercise.

Hospital groupTelerehabilitation group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with survival period breast cancer will be taken
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18 and 65
  • Literate
  • Having a diagnosis of breast cancer stage 1-2
  • Complete breast cancer primary treatment at least 6 months before (excluding hormone therapy/aromatase inhibitors)
  • Providing the cooperation
  • Be woman
  • Physically inactive (60 minutes of structured exercise per week \<)
  • Patients willing and voluntarily to participate in the study

You may not qualify if:

  • Who are using one of the psychotic, anxiolytic, antidepressant, analgesic and sleeping pills
  • With metastases
  • Those with a history of lymphedema
  • With neurological disease
  • Those who are pregnant or breastfeeding
  • Uncontrolled hypertensive patients
  • Those incapable of verbal communication or physical movement
  • Patients who did not agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramazan Cihad Yılmaz

Gaziantep, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ramazan Cihad Yılmaz

CONTACT

+905070364611fzt.yilmaz.cihad@gmail.com

Deniz KOCAMAZ

CONTACT

deniz.erdankocamaz@hku.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

November 27, 2022

First Posted

February 9, 2023

Study Start

October 20, 2022

Primary Completion

May 30, 2023

Study Completion

December 30, 2023

Last Updated

February 9, 2023

Record last verified: 2023-01

Locations

TU(1)