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OpenTrials
Completed

NCT Number: NCT04259593

Exercise for Elderly Lymphoma Patients

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.

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Key information

Conditions

Elderly Lymphoma Patients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sant'Andrea Hospital

Rome, 00189, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training

Other

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. Safety of the exercise training

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2020
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.