Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:08 AM
Study NCT ID:
NCT07368192
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community-Based Exercise Oncology: Real-World Evidence of High Adherence, Improved Quality of Life and Cost-Effectiveness Across the Cancer Continuum
Sponsor:
University of Castilla-La Mancha
Organization:
Study Overview
Official Title:
Community-Based Exercise Oncology: Real-World Evidence of High Adherence, Improved Quality of Life and Cost-Effectiveness Across the Cancer Continuum
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective observational cohort study evaluates a community-based supervised exercise oncology program delivered in real-world settings in Madrid, Spain. The program is designed for adults with a cancer diagnosis across the cancer continuum, including survivors, patients undergoing active treatment, individuals receiving hormonotherapy, and patients with metastatic disease.
Participants take part in a structured multimodal exercise program combining aerobic, resistance, and functional training, delivered in supervised group-based sessions either in person or through synchronous online formats. The primary aims of the study are to assess program adherence, health-related quality of life, fatigue, and cost-effectiveness, expressed as quality-adjusted life years (QALYs). Secondary outcomes include cardiorespiratory fitness, muscular strength, functional capacity, physical activity levels, body composition, and psychological well-being.
Assessments are conducted at baseline and every four months over a 12-month follow-up period. This study provides real-world evidence on the feasibility, clinical impact, and economic value of community-based exercise oncology programs across different stages of the cancer trajectory.
Participants take part in a structured multimodal exercise program combining aerobic, resistance, and functional training, delivered in supervised group-based sessions either in person or through synchronous online formats. The primary aims of the study are to assess program adherence, health-related quality of life, fatigue, and cost-effectiveness, expressed as quality-adjusted life years (QALYs). Secondary outcomes include cardiorespiratory fitness, muscular strength, functional capacity, physical activity levels, body composition, and psychological well-being.
Assessments are conducted at baseline and every four months over a 12-month follow-up period. This study provides real-world evidence on the feasibility, clinical impact, and economic value of community-based exercise oncology programs across different stages of the cancer trajectory.
Detailed Description:
This study is a prospective observational cohort analysis of adults with a confirmed cancer diagnosis participating in a community-based supervised exercise oncology program in Madrid, Spain. Participants are referred by oncology specialists or self-referred with medical clearance to engage in moderate-intensity physical exercise.
The intervention consists of supervised multimodal exercise sessions lasting approximately 75 minutes, including warm-up, combined aerobic and resistance training, and cool-down periods. Aerobic training is prescribed using heart rate reserve and perceived exertion scales, while resistance training includes free-weight and functional exercises targeting major muscle groups. Sessions are delivered in small groups either face-to-face or via synchronous online platforms, with individualized progression and safety monitoring.
Participants undergo standardized assessments at baseline and at 4, 8, and 12 months. Primary outcomes include adherence to supervised exercise sessions, health-related quality of life, fatigue, and cost-effectiveness measured through quality-adjusted life years derived from EQ-5D instruments. Secondary outcomes include estimated cardiorespiratory fitness, muscular strength, functional capacity tests, physical activity behavior, body composition, and psychological outcomes.
The study aims to generate real-world evidence on the feasibility, effectiveness, and economic impact of integrating structured exercise programs into community-based cancer care across different clinical stages of disease.
The intervention consists of supervised multimodal exercise sessions lasting approximately 75 minutes, including warm-up, combined aerobic and resistance training, and cool-down periods. Aerobic training is prescribed using heart rate reserve and perceived exertion scales, while resistance training includes free-weight and functional exercises targeting major muscle groups. Sessions are delivered in small groups either face-to-face or via synchronous online platforms, with individualized progression and safety monitoring.
Participants undergo standardized assessments at baseline and at 4, 8, and 12 months. Primary outcomes include adherence to supervised exercise sessions, health-related quality of life, fatigue, and cost-effectiveness measured through quality-adjusted life years derived from EQ-5D instruments. Secondary outcomes include estimated cardiorespiratory fitness, muscular strength, functional capacity tests, physical activity behavior, body composition, and psychological outcomes.
The study aims to generate real-world evidence on the feasibility, effectiveness, and economic impact of integrating structured exercise programs into community-based cancer care across different clinical stages of disease.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: