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Clinical Trials/NCT04259593
NCT04259593
Completed
Not Applicable

Exercise Training is a Feasible and Active Complementary Therapy in Adult and Elderly Patients Receiving Anti- Lymphoma Treatments

University of Roma La Sapienza1 site in 1 country30 target enrollmentJanuary 2, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elderly Lymphoma Patients
Sponsor
University of Roma La Sapienza
Enrollment
30
Locations
1
Primary Endpoint
The eligibility rate
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This pilot study was designed in a real-life setting to establish the feasibility, the safety and the activity of a supervised and combined Exercise Training (ET) program in adult and elderly lymphoma patients undergoing cancer-treatments.

Detailed Description

Eligible patients were assigned to the ET group. All the patients eligible for exercise but not partiticpating to the ET program because of logistical reasons, were considered as the control group. All clinical outcomes were assessed before exercise training (T0), 3 (T1) and 6-months (T2) after the beginning of the exercise.

Registry
clinicaltrials.gov
Start Date
January 2, 2016
End Date
May 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Roma La Sapienza
Responsible Party
Principal Investigator
Principal Investigator

Mario Vetrano, MD

MD, PhD

University of Roma La Sapienza

Eligibility Criteria

Inclusion Criteria

  • ≥18-80 years old, histologically confirmed HL or NHL, patients in need of first or subsequent lines of systemic treatment and with a long-life expectancy

Exclusion Criteria

  • Patients were excluded if they had less than 4 months of anti-cancer treatment to be delivered, severe orthopaedic, cardiac, pulmonary, or cognitive impairment, osteolytic lesions with the risk of fracture, cachexia or if they were ≥ 65 years and frail on the basis of comprehensive geriatric assessment

Outcomes

Primary Outcomes

The eligibility rate

Time Frame: 6 months

the eligibility rate was assessed by the number of eligible patients divided by the total number of elements on the sampling frame.

Safety of the exercise training

Time Frame: 6 months

Safety was assessed by monitoring any serious adverse events that occured during the ET period.

The recruitment rate

Time Frame: 6 months

the recruitment rate was assessed by the number of patients included in the study divided by the total number of eligible patients

The exercise adherence rate

Time Frame: 4 months

The exercise adherence rate was assessed by the number of exercise sessions attended out of the 48 sessions scheduled for each patient

The assessment rate

Time Frame: 6 months

The assessment rate was assessed by the number of patients who completed the T1 and T2 follow-up times over the total number who participated in the study

Study Sites (1)

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