Exercise for Elderly Lymphoma Patients

NCT04259593 | Completed

• 1 other identifier: 553
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Lymphoma Patients

Keywords

Exercise training, Complementary therapy

Outcome Measures

Primary Outcomes (5)

• The eligibility rate

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

  6 months

• The recruitment rate

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

  6 months

• The exercise adherence rate

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

  4 months

• The assessment rate

  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

  6 months

• Safety of the exercise training

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

  6 months

Study Arms (2)

Exercise Training Group

EXPERIMENTAL

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.

Other: exercise training

Control Group

NO INTERVENTION

The control group received usual lymphoma care

Interventions

exercise training OTHER

Exercise Training Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sant'Andrea Hospital

Rome, 00189, Italy

Location

Related Publications (1)

• 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.

  PMID: 24478323 BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maria Christina Cox

  Sant'Andrea Hospital, Rome, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 6, 2020
• Study Start: January 2, 2016
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)