Exercise for Elderly Lymphoma Patients

Not Applicable

Completed

• Conditions: Elderly Lymphoma Patients
• Interventions: Other: exercise training

• Registration Number: NCT04259593
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study Start: 2016-01-02
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2020-02
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Last Update Submitted: 2020-02-05
• Study First Posted: 2020-02-06
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Training Group	exercise training	Exercise training group performed three weekly sessions for 16 weeks. This program consisted of moderate intensity aerobic, resistance, balance, and stretching exercises. The duration of every exercise session was 35 minutes during the first week and 65 minutes from the second week onward.

Primary Outcome Measures

Name	Time	Method
The eligibility rate	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	6 months	Safety was assessed by monitoring any serious adverse events that occured during the ET period.
The recruitment rate	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	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	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

Trial Locations

Locations (1)

Sant'Andrea Hospital; 🇮🇹 Rome, Italy