Exercise for Elderly Lymphoma Patients
Primary Purpose
Elderly Lymphoma Patients
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
exercise training
Sponsored by
About this trial
This is an interventional supportive care trial for Elderly Lymphoma Patients focused on measuring Exercise training, Complementary therapy
Eligibility Criteria
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
Sites / Locations
- Sant'Andrea Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise Training Group
Control Group
Arm Description
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.
The control group received usual lymphoma care
Outcomes
Primary Outcome Measures
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.
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
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
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
Safety of the exercise training
Safety was assessed by monitoring any serious adverse events that occured during the ET period.
Secondary Outcome Measures
Full Information
NCT ID
NCT04259593
First Posted
February 5, 2020
Last Updated
February 5, 2020
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT04259593
Brief Title
Exercise for Elderly Lymphoma Patients
Official Title
Exercise Training is a Feasible and Active Complementary Therapy in Adult and Elderly Patients Receiving Anti- Lymphoma Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2016 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Lymphoma Patients
Keywords
Exercise training, Complementary therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Training Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group received usual lymphoma care
Intervention Type
Other
Intervention Name(s)
exercise training
Primary Outcome Measure Information:
Title
The eligibility rate
Description
the eligibility rate was assessed by the number of eligible patients divided by the total number of elements on the sampling frame.
Time Frame
6 months
Title
The recruitment rate
Description
the recruitment rate was assessed by the number of patients included in the study divided by the total number of eligible patients
Time Frame
6 months
Title
The exercise adherence rate
Description
The exercise adherence rate was assessed by the number of exercise sessions attended out of the 48 sessions scheduled for each patient
Time Frame
4 months
Title
The assessment rate
Description
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
Time Frame
6 months
Title
Safety of the exercise training
Description
Safety was assessed by monitoring any serious adverse events that occured during the ET period.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Christina Cox
Organizational Affiliation
Sant'Andrea Hospital, Rome, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Sant'Andrea Hospital
City
Rome
ZIP/Postal Code
00189
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24478323
Citation
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.
Results Reference
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Exercise for Elderly Lymphoma Patients
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