Exercise for Elderly Lymphoma Patients

Elderly Lymphoma Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259593
• Other study ID #: 553
• Status: Completed
• Phase: N/A
• Start date: January 2, 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: February 2020
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• =18-80 years old, histologically con?rmed 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

Related Conditions & MeSH terms

• Elderly Lymphoma Patients
• Lymphoma

Intervention

Other:
• exercise training

Locations

Country	Name	City	State
Italy	Sant'Andrea Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Streckmann F, Kneis S, Leifert JA, Baumann FT, Kleber M, Ihorst G, Herich L, Grüssinger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Safety of the exercise training	Safety was assessed by monitoring any serious adverse events that occured during the ET period.	6 months