Exercise for Elderly Lymphoma Patients

NCT ID: NCT04259593

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-02

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Elderly Lymphoma Patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise Training Group

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.

Group Type EXPERIMENTAL

exercise training

Intervention Type OTHER

Control Group

The control group received usual lymphoma care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Mario Vetrano, MD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Christina Cox

Role: STUDY_CHAIR

Sant'Andrea Hospital, Rome, Italy

Locations

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Sant'Andrea Hospital

Rome, , Italy

Site Status

Countries

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Italy

References

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Streckmann F, Kneis S, Leifert JA, Baumann FT, Kleber M, Ihorst G, Herich L, Grussinger V, Gollhofer A, Bertz H. Exercise program improves therapy-related side-effects and quality of life in lymphoma patients undergoing therapy. Ann Oncol. 2014 Feb;25(2):493-9. doi: 10.1093/annonc/mdt568.

Reference Type BACKGROUND
PMID: 24478323 (View on PubMed)

Other Identifiers

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553

Identifier Type: -

Identifier Source: org_study_id

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