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Trial Title:
Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma
NCT ID:
NCT05700747
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple Myeloma
Physical Therapy
Exercise Program
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Health Through Activity
Description:
Six, weekly, customized sessions with licensed physical and occupational therapists.
Arm group label:
Health Through Activity (HTA) Intervention
Summary:
The purpose of this study is to explore whether a structured program can help reduce the
challenges of decreased physical functioning and quality of life for participants with
multiple myeloma by providing a customized exercise program and fostering engagement in
meaningful activities.
The name of the study intervention involved in this study is:
Health Through Activity (HTA) (six-session, rehabilitation exercise regimen)
Detailed description:
The goal of this single arm, pilot study of the Health Through Activity (HTA)
rehabilitation intervention for people living with multiple myeloma is to determine if
investigators can feasibly deliver the program out of the IMPACT Practice Center at the
MGH Institute for Health Professions.
- The six-session 'Health Through Activity' program provides a customized exercise
plan and encourages engagement in activities to reduce disability and improve
quality of life.
- Study procedures including screening for eligibility, in-clinic visits,
questionnaires, and surveys.
- Participation in this research study is expected to last up to 4 months.
It is expected that up to 20 people will take part in this research study.
An internal grant from the Massachusetts General Hospital Institute of Health Professions
is providing equipment and staffing for this study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-≥18 years of age
- Diagnosed with multiple myeloma currently receiving maintenance therapy,
- Experiencing disability as indicated by an answer of "yes" to the question "Do
health problems interfere with your ability to carry out your social or day to day
activities?"
Exclusion Criteria:
- Bone pain that is either a) new onset or increased in the past month or b)
uncontrolled i.e., in the patient's estimation the bone pain "greatly interferes
with daily activities"
- History of fracture in the past 12 months without fixation, or
- Any injury or medical condition that would prohibit being able to safely perform
exercise as indicated by the Physical Activity Readiness Questionnaire[29] (i.e.,
atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or
hypertension, loss of balance due to dizziness in the past 12 months, or loss of
consciousness in the past 12 months).
- We will also exclude individuals with moderate or worse cognitive impairment as
indicated by a score of 3 or less on the Callahan six item cognitive screening tool.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Start date:
February 1, 2023
Completion date:
February 28, 2026
Lead sponsor:
Agency:
MGH Institute of Health Professions
Agency class:
Other
Source:
MGH Institute of Health Professions
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05700747
