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Personalized Live-remote Exercise Training for Cancer Survivors - Trial NCT06270628

Access comprehensive clinical trial information for NCT06270628 through Pure Global AI's free database. This phase not specified trial is sponsored by UMC Utrecht and is currently Not yet recruiting. The study focuses on Neoplasms. Target enrollment is 350 participants.

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NCT06270628
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behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06270628
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Personalized Live-remote Exercise Training for Cancer Survivors
Demonstrating the (Cost-)Effectiveness of a Personalized Live-remote Exercise Intervention for Cancer Survivors Using a Super Umbrella Randomized Controlled Trial: the LION RCT

Study Focus

Neoplasms

Exercise group

Interventional

behavioral

Sponsor & Location

UMC Utrecht

Utrecht, Netherlands

Timeline & Enrollment

N/A

Feb 20, 2024

Oct 31, 2027

350 participants

Primary Outcome

Health-Related Quality of Life,A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline,A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline,A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline,A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline

Summary

Background
 
 Many people with cancer face ongoing problems from their disease and treatments, like
 fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise
 might help with these problems, most studies did not focus on tailoring exercise to address
 these specific complaints. Exercise programs under supervision (like with a trainer) seem to
 work better, but barriers for following such sessions are travel distance and time.
 Therefore, following an exercise program at home with a trainer guiding via video
 (live-remote) might be a good solution. But, it is unclear how effective this remote exercise
 program is for cancer patients.
 
 Goal of the study:
 
 The main goal of this study is to assess the effectiveness of a personalized, live-remote
 exercise intervention for cancer survivors on quality of life and the patients' main
 complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical
 functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy.
 
 Design of the study
 
 In the LION study, 350 cancer patients will be randomly divided into the exercise group or
 control group. These patients all have at least one of these complaints: 1) fatigue, 2)
 reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy.
 Patients cannot participate in the study if they are already very active.
 
 The exercise group will start a 12-week exercise program right away, and the other group will
 wait for 12 weeks before starting. The exercise program consists of three sessions per week.
 Two sessions per week include aerobic training and strength training. These sessions will be
 followed by all patients; and aim to improve fitness and strength. The third session
 specifically aims at improvement of the main complaint, for example fatigue.
 
 Participants will get an app and a fitness tracker to help them stay on track with their
 exercises. Furthermore, patients get information on the effects of exercise for cancer
 patients and why exercise is important for specific complaints.
 
 Measurements
 
 The main outcomes of this study are quality of life and the main side-effect of the patient.
 Other measurements include all kind of patient reported outcomes (like sleep problems and
 pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory)
 markers in blood.
 
 Conclusion:
 
 This study investigates if personalized exercises done at home, with video guidance, can make
 cancer survivors feel better and manage their side effects more effectively.

ICD-10 Classifications

Neoplasms
In situ neoplasms
Personal history of other neoplasms
Benign neoplasms
Malignant neoplasms

Data Source

ClinicalTrials.gov

NCT06270628

Non-Device Trial