Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537336
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Optimizing Pulmonary Health and Quality of Life in Breast Cancer Survivors A Randomized Controlled Trial Combining Incentive Spirometry and Aerobic Exercise
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Pulmonary Health and Quality of Life in Breast Cancer Survivors A Randomized Controlled Trial Combining Incentive Spirometry and Aerobic Exercise
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer survivors frequently experience diminished lung function and decreased quality of life QoL following radiation therapy RT Additionally incentive spirometry which encourages prolonged deep breathing could potentially amplify lung function and QoL when paired with aerobic exercises This study investigated the combined effect of aerobic and breathing exercises using incentive spirometry on lung function and QoL in patients with breast cancer after RT
Detailed Description:
Study Design This experimental study employed a single-blind randomized controlled trial design with two groups Consecutive sampling was conducted based on the order of arrival Group allocation control group with aerobic exercise or treatment group with incentive spirometry breathing exercises combined with aerobic exercise was determined using a simple random sampling method with a lottery The data were analyzed using SPSS version 250
Participants Participants were patients with breast cancer who had completed Radiotherapy at Hasan Sadikin General Hospital Bandung between April 2023 and June 2023
Research Procedure Patients were initially selected based on the inclusion and exclusion criteria and informed consent was obtained Before and after the intervention lung function tests using spirometry and QoL measurements were conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 EORTC-QLQ-C30 The EORTC-QLQ-C30 was designed to assess seven domains of QoL in cancer patients physical functioning role functioning emotional functioning cognitive functioning social functioning overall health status and symptom domains The EORTC-QLQ-C30 questionnaire has been translated into Indonesian from Dyah APs research and has shown validity scores 070 and reliability scores 080 in evaluating the QoL of cancer patients undergoing therapy14 The patients in the treatment group underwent aerobic and volumetric incentive spirometry breathing exercises The control group performed only aerobic exercise
The aerobic exercise program was conducted over 8 weeks using a stationary bicycle The training frequency was three times per week Each session lasted 40 min consisting of 5 min of warm-up 30 min of main exercise and 5 min of cool-down The exercise intensity was moderate RPE 12-13
Volumetric incentive spirometry exercises were performed 15 min after completing the aerobic exercise This exercise used sustained maximal incentive spirometry Voldyne 5000 The program was conducted over eight weeks with a training frequency of three times per week Each session included five sets of exercises with each set consisting of 10 breathing repetitions and a 1-minute rest between sets The intensity of this exercise involved performing maximal inspiration from the residual volume RV to the total lung capacity TLC that the subject could achieve The inspiratory volume reached was used as the target for subsequent training sessions
Participants Participants were patients with breast cancer who had completed Radiotherapy at Hasan Sadikin General Hospital Bandung between April 2023 and June 2023
Research Procedure Patients were initially selected based on the inclusion and exclusion criteria and informed consent was obtained Before and after the intervention lung function tests using spirometry and QoL measurements were conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires-Core30 EORTC-QLQ-C30 The EORTC-QLQ-C30 was designed to assess seven domains of QoL in cancer patients physical functioning role functioning emotional functioning cognitive functioning social functioning overall health status and symptom domains The EORTC-QLQ-C30 questionnaire has been translated into Indonesian from Dyah APs research and has shown validity scores 070 and reliability scores 080 in evaluating the QoL of cancer patients undergoing therapy14 The patients in the treatment group underwent aerobic and volumetric incentive spirometry breathing exercises The control group performed only aerobic exercise
The aerobic exercise program was conducted over 8 weeks using a stationary bicycle The training frequency was three times per week Each session lasted 40 min consisting of 5 min of warm-up 30 min of main exercise and 5 min of cool-down The exercise intensity was moderate RPE 12-13
Volumetric incentive spirometry exercises were performed 15 min after completing the aerobic exercise This exercise used sustained maximal incentive spirometry Voldyne 5000 The program was conducted over eight weeks with a training frequency of three times per week Each session included five sets of exercises with each set consisting of 10 breathing repetitions and a 1-minute rest between sets The intensity of this exercise involved performing maximal inspiration from the residual volume RV to the total lung capacity TLC that the subject could achieve The inspiratory volume reached was used as the target for subsequent training sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None