Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:34 PM
Study NCT ID:
NCT07440433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-Based Physiotherapy in Oncology
Sponsor:
University Hospital, Geneva
Organization:
Study Overview
Official Title:
Home-Based Physiotherapy for Oncology Patients: Feasibility and Acceptability of a Supervised Exercise Programme
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
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:
The goal of this clinical trial is to assess the feasibility, acceptability, and safety of a supervised home-based physiotherapy programme for adult oncology patients. The programme combines aerobic cycling exercise, resistance training, and mental preparation strategies, delivered at home with regular professional supervision.
The main questions this study aims to answer are:
Is a 6-month supervised home-based physiotherapy programme feasible in terms of recruitment, adherence, and retention?
Is the programme safe for oncology patients undergoing or having recently completed cancer treatment?
Is the programme acceptable and satisfactory from the patient's perspective?
How do physical function and health-related quality of life change over the course of the programme?
This is a single-arm feasibility study with no comparison group.
Participants will:
Receive a stationary exercise bike delivered and installed at their home
Follow a 6-month individualized physiotherapy programme including:
Three weekly sessions combining moderate-intensity cycling and resistance exercises
Wear a connected activity watch during exercise sessions to monitor heart rate and exercise duration
Receive weekly supervision from oncology-trained physiotherapists through alternating in-person hospital visits and structured phone calls
Complete physical function assessments and questionnaires on quality of life, fatigue, and programme satisfaction at baseline, mid-program, and study completion
The results of this study will inform the design of a future larger controlled trial and contribute to the development of accessible home-based rehabilitation programmes for oncology patients.
The main questions this study aims to answer are:
Is a 6-month supervised home-based physiotherapy programme feasible in terms of recruitment, adherence, and retention?
Is the programme safe for oncology patients undergoing or having recently completed cancer treatment?
Is the programme acceptable and satisfactory from the patient's perspective?
How do physical function and health-related quality of life change over the course of the programme?
This is a single-arm feasibility study with no comparison group.
Participants will:
Receive a stationary exercise bike delivered and installed at their home
Follow a 6-month individualized physiotherapy programme including:
Three weekly sessions combining moderate-intensity cycling and resistance exercises
Wear a connected activity watch during exercise sessions to monitor heart rate and exercise duration
Receive weekly supervision from oncology-trained physiotherapists through alternating in-person hospital visits and structured phone calls
Complete physical function assessments and questionnaires on quality of life, fatigue, and programme satisfaction at baseline, mid-program, and study completion
The results of this study will inform the design of a future larger controlled trial and contribute to the development of accessible home-based rehabilitation programmes for oncology patients.
Detailed Description:
This study is a prospective, single-centre, single-arm feasibility clinical trial conducted at the Geneva University Hospitals (HUG). It evaluates the implementation of a long-duration supervised home-based physiotherapy programme for adult oncology patients.
A total of 21 participants will be enrolled in three sequential cohorts of approximately seven participants each. Each participant will follow a single 6-month intervention period; cohorts are implemented sequentially for logistical and organisational reasons but follow identical study procedures.
The intervention consists of a 6-month home-based physiotherapy programme combining aerobic cycling exercise, resistance training, and mental preparation strategies. At study initiation, a stationary exercise bike is delivered and installed in the participant's home. An individualized exercise prescription is developed by oncology-trained physiotherapists based on baseline functional assessments and clinical status.
Participants are asked to complete three supervised exercise sessions per week. Each session includes approximately 20 minutes of moderate-intensity aerobic cycling followed by 20 minutes of resistance training. Exercise intensity is prescribed and monitored using perceived exertion and heart rate criteria consistent with current oncology exercise guidelines. A connected activity watch is provided to each participant and worn only during exercise sessions to record heart rate and exercise duration.
Supervision is ensured through weekly contact with oncology physiotherapists, alternating between in-person hospital visits and structured telephone calls. In-person visits include functional reassessments, programme adjustments, symptom review, safety monitoring, and mental preparation sessions. Mental preparation integrates motivational interviewing techniques, goal setting, routine development, and basic mindfulness and imagery strategies aimed at supporting adherence and self-management.
The primary focus of the study is feasibility, assessed through recruitment capability, adherence to prescribed exercise sessions, participant retention over the 6-month period, and successful delivery and use of the home-based equipment. Safety is assessed through systematic monitoring and reporting of adverse events related to the intervention.
Secondary outcomes include changes in physical function and patient-reported outcomes. Functional performance is assessed using standardized physical tests at baseline and at the end of the intervention. Patient-reported outcomes, including health-related quality of life, fatigue, and programme acceptability, are collected at baseline, mid-program (3 months), and study completion (6 months).
All analyses are descriptive and aim to provide feasibility indicators and operational insights to inform the design of a future controlled trial and potential integration of supervised home-based physiotherapy into routine oncology care.
A total of 21 participants will be enrolled in three sequential cohorts of approximately seven participants each. Each participant will follow a single 6-month intervention period; cohorts are implemented sequentially for logistical and organisational reasons but follow identical study procedures.
The intervention consists of a 6-month home-based physiotherapy programme combining aerobic cycling exercise, resistance training, and mental preparation strategies. At study initiation, a stationary exercise bike is delivered and installed in the participant's home. An individualized exercise prescription is developed by oncology-trained physiotherapists based on baseline functional assessments and clinical status.
Participants are asked to complete three supervised exercise sessions per week. Each session includes approximately 20 minutes of moderate-intensity aerobic cycling followed by 20 minutes of resistance training. Exercise intensity is prescribed and monitored using perceived exertion and heart rate criteria consistent with current oncology exercise guidelines. A connected activity watch is provided to each participant and worn only during exercise sessions to record heart rate and exercise duration.
Supervision is ensured through weekly contact with oncology physiotherapists, alternating between in-person hospital visits and structured telephone calls. In-person visits include functional reassessments, programme adjustments, symptom review, safety monitoring, and mental preparation sessions. Mental preparation integrates motivational interviewing techniques, goal setting, routine development, and basic mindfulness and imagery strategies aimed at supporting adherence and self-management.
The primary focus of the study is feasibility, assessed through recruitment capability, adherence to prescribed exercise sessions, participant retention over the 6-month period, and successful delivery and use of the home-based equipment. Safety is assessed through systematic monitoring and reporting of adverse events related to the intervention.
Secondary outcomes include changes in physical function and patient-reported outcomes. Functional performance is assessed using standardized physical tests at baseline and at the end of the intervention. Patient-reported outcomes, including health-related quality of life, fatigue, and programme acceptability, are collected at baseline, mid-program (3 months), and study completion (6 months).
All analyses are descriptive and aim to provide feasibility indicators and operational insights to inform the design of a future controlled trial and potential integration of supervised home-based physiotherapy into routine oncology care.
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?: