- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07376213
Effects of a Home-Based Exercise Program During Radiotherapy
January 29, 2026 updated by: Burak Ertürk
Investigation of the Effects of Home-Based Exercise Program Applied During Radiotherapy on Posture, Range of Motion, Muscle Strength, Fibrosis, Lymphedema and Swallowing Functions in Patients Diagnosed With Head and Neck Cancer
The purpose of this study is to examine the effects of exercise on individuals with head and neck cancer who are receiving postoperative radiotherapy.
The study is based on three primary hypotheses:
- Exercise may help reduce or prevent the loss of normal range of motion that can occur during radiotherapy.
- Exercise may help maintain muscle strength or lead to improvements in muscle strength.
- Exercise may help maintain or improve postural alignment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Gazi University, Faculty of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of squamous cell carcinoma of the head and neck.
- Undergoing unilateral neck dissection surgery.
- Scheduled to receive curative radiotherapy.
- Age 18 years or older.
- Willingness to participate and ability to comprehend exercise instructions.
Exclusion Criteria:
- Presence of distant metastasis.
- Presence of a tracheostomy.
- History of previous trauma or surgery involving the shoulder or cervical region.
- Neurological disorders affecting upper quadrant function. Recurrence of disease during the study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Structured Home-Based Physiotherapy Program
Participants in the intervention group will receive instruction in a structured home-based exercise program to be implemented throughout the radiotherapy period.
Adherence, technique, and progression will be monitored and reinforced through weekly in-person sessions with a qualified professional.
|
The home-based rehabilitation approach was conducted for the patients, consisting of neck and upper extremity mobilization, strengthening, stretching, and breathing exercises, 5 days a week.
|
|
No Intervention: Usual Care / Standard Follow-Up
Participants in the control group will receive only radiotherapy and will not undergo any physiotherapy interventions during this period.
At the end of the radiotherapy, both groups will be re-evaluated, and participants in the control group will then be provided with appropriate treatment and home-based exercise programs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion
Time Frame: Baseline and Day 25 (end of radiotherapy)
|
Range of motion of the cervical region will be assessed using a cervical range of motion (CROM) device, and shoulder range of motion will be assessed using a goniometer, including flexion, extension, lateral flexion, rotation, abduction, and external rotation.
|
Baseline and Day 25 (end of radiotherapy)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength
Time Frame: Baseline and Day 25 (end of radiotherapy)
|
Muscle strength of the cervical and shoulder girdle muscles will be evaluated using manual muscle testing.
|
Baseline and Day 25 (end of radiotherapy)
|
|
Postural Alignment
Time Frame: Baseline and Day 25 (end of radiotherapy)
|
Postural alignment will be assessed through observational postural analysis focusing on head, neck, and shoulder alignment.
|
Baseline and Day 25 (end of radiotherapy)
|
|
Fibrosis Severity
Time Frame: Day 25 (end of radiotherapy)
|
Radiation-induced fibrosis will be evaluated using a standardized clinical fibrosis grading scale.
|
Day 25 (end of radiotherapy)
|
|
Lymphedema
Time Frame: Day 25 (end of radiotherapy)
|
Head and neck lymphedema will be assessed using circumferential measurements and/or clinical lymphedema grading.
|
Day 25 (end of radiotherapy)
|
|
Swallowing Function
Time Frame: Baseline and Day 25 (end of radiotherapy)
|
Swallowing function will be evaluated using a validated swallowing assessment scale (Swal-QoL).
|
Baseline and Day 25 (end of radiotherapy)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2022
Primary Completion (Actual)
January 15, 2025
Study Completion (Actual)
January 15, 2025
Study Registration Dates
First Submitted
January 21, 2026
First Submitted That Met QC Criteria
January 21, 2026
First Posted (Actual)
January 29, 2026
Study Record Updates
Last Update Posted (Actual)
February 2, 2026
Last Update Submitted That Met QC Criteria
January 29, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77082166-302.08.01-805534
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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