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Prehabilitation Feasibility Among Older Adults Undergoing Transplantation

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-modal Exercise Regimen
Dietary Guidelines
Sponsored by
Smith Giri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Myeloma focused on measuring Autologous Stem Cell Transplant

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Multiple Myeloma Scheduled for ASCT at UAB within 10 weeks of study enrollment age at ASCT ≥60y Exclusion Criteria: at high risk for impending pathologic fracture using Mirels score

Sites / Locations

  • Kirklin Clinic of UAB HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Teleprehab

Attention Control

Arm Description

The participants selected for the teleprehab arm will undergo a supervised 8-week multi-modal exercise program in a telehealth format (using doxy.me, a free telehealth platform) delivered by licensed physical or occupational therapists who have undergone cancer specific rehabilitation training within Select Medical's ReVital® cancer rehabilitation program. Participants will attend teleprehab sessions 2 times per week for a total of 16 sessions.

The participants randomized to the attention control arm will not undergo an exercise regimen, but will be contacted by the study staff on the phone once a week..

Outcomes

Primary Outcome Measures

Participation rate
Participation rate will be measured as the number of participants agreeing to participate in the study divided by total participants approached for the study.
Completion rate
Completion rate will be measured as the number of participants completing the study intervention phase (8 weeks) divided by the total number of participants starting the intervention.
Adherence rate
Adherence rate will be computed Number of participants attending at least 80% of the planned intervention sessions divided by the total number of participants initiating the intervention.
Acceptability
Acceptability of intervention will be measured using a) 9-item Theoretical Framework of Acceptability Questionnaire which measures participants perspectives on the acceptability of the study intervention. Responses are measured in a likert type scale. and b) a semi-structured interview that will be focused on gathering overall acceptability of the intervention to the participants. Interview questions will be focused on understanding participants perspectives using 7 different proposed constructs of acceptability, i.e affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self efficacy.

Secondary Outcome Measures

Change in Lower Extremity Physical Function
Investigators will measure lower extremity physical function using the Short Physical Performance Battery Scores (SPPB, score 0-12; higher score indicates better physical function) and compare the difference in SPPB scores before and after intervention
Change in Functional Exercise Capacity
Investigators will measure functional exercise capacity using 6-minute walking distance (6MWD) and compare the difference in 6MWD before and after intervention
Change in mobility
Investigators will measure mobility of study participants using the 9-item life space questionnaire (LSQ; score range 0-120, higher scores indicate better mobility) and compare the difference in LSQ before and after intervention
Change in functional status
Investigators will measure functional status using the Older Americans Resources and Services (OARS) Activities of Daily Living and Instrumental Activities of Daily Living (ADL/IADL) compare the difference in ADL/IADL scores before and after intervention

Full Information

First Posted
November 10, 2022
Last Updated
July 11, 2023
Sponsor
Smith Giri
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1. Study Identification

Unique Protocol Identification Number
NCT05642884
Brief Title
Prehabilitation Feasibility Among Older Adults Undergoing Transplantation
Official Title
Feasibility of a Prehabilitation Intervention Among Older Adults With Myeloma Receiving Autologous Stem Cell Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Smith Giri

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo Autologous Stem Cell transplantation at UAB. Participants will be randomized into either a prehabilitation program or an attention control group before their transplant. The primary outcomes will be feasibility and secondary outcomes include changes in physical function at the time of transplant and at 12 weeks follow up.
Detailed Description
This is a pilot randomized trial of older adults 60y and above planned to undergo Autologous Stem Cell Transplant for Multiple Myeloma. Eligible participants will be randomized (like flipping a coin) to one of two study conditions: 1) an 8 week long home-based prehabilitation exercise program delivered using a telehealth format or 2) an 8-week long nutrition counseling (attention control group). Assessments will occur at baseline, post-intervention (during transplant) and at 12-weeks post-transplant. Investigators will assess the feasibility and acceptability of our program as well as preliminary impact of the program on physical functioning during these time-periods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Autologous Stem Cell Transplant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We plan to enroll a total of 30 patients, randomized 1:1 using permuted block algorithm stratified by sex and age (e.g. 60-70, >70y), into intervention arm (home based prehabilitation) vs an attention control (dietary counseling) group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teleprehab
Arm Type
Experimental
Arm Description
The participants selected for the teleprehab arm will undergo a supervised 8-week multi-modal exercise program in a telehealth format (using doxy.me, a free telehealth platform) delivered by licensed physical or occupational therapists who have undergone cancer specific rehabilitation training within Select Medical's ReVital® cancer rehabilitation program. Participants will attend teleprehab sessions 2 times per week for a total of 16 sessions.
Arm Title
Attention Control
Arm Type
Other
Arm Description
The participants randomized to the attention control arm will not undergo an exercise regimen, but will be contacted by the study staff on the phone once a week..
Intervention Type
Other
Intervention Name(s)
Multi-modal Exercise Regimen
Intervention Description
Participants will undergo a total of 16 sessions over 8 weeks. Each therapy session will comprise of patient education, including facilitated goal planning, promotion of physical activity and safe exercise guideline, followed by 30 minutes of preferred aerobic activity such as walking or biking.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Guidelines
Intervention Description
Participants will be contacted once a week to review dietary recommendations per the 2022 American Cancer Society guidelines for cancer survivors.
Primary Outcome Measure Information:
Title
Participation rate
Description
Participation rate will be measured as the number of participants agreeing to participate in the study divided by total participants approached for the study.
Time Frame
1 year
Title
Completion rate
Description
Completion rate will be measured as the number of participants completing the study intervention phase (8 weeks) divided by the total number of participants starting the intervention.
Time Frame
1 year
Title
Adherence rate
Description
Adherence rate will be computed Number of participants attending at least 80% of the planned intervention sessions divided by the total number of participants initiating the intervention.
Time Frame
1 year
Title
Acceptability
Description
Acceptability of intervention will be measured using a) 9-item Theoretical Framework of Acceptability Questionnaire which measures participants perspectives on the acceptability of the study intervention. Responses are measured in a likert type scale. and b) a semi-structured interview that will be focused on gathering overall acceptability of the intervention to the participants. Interview questions will be focused on understanding participants perspectives using 7 different proposed constructs of acceptability, i.e affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self efficacy.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in Lower Extremity Physical Function
Description
Investigators will measure lower extremity physical function using the Short Physical Performance Battery Scores (SPPB, score 0-12; higher score indicates better physical function) and compare the difference in SPPB scores before and after intervention
Time Frame
1 year
Title
Change in Functional Exercise Capacity
Description
Investigators will measure functional exercise capacity using 6-minute walking distance (6MWD) and compare the difference in 6MWD before and after intervention
Time Frame
1 year
Title
Change in mobility
Description
Investigators will measure mobility of study participants using the 9-item life space questionnaire (LSQ; score range 0-120, higher scores indicate better mobility) and compare the difference in LSQ before and after intervention
Time Frame
1 year
Title
Change in functional status
Description
Investigators will measure functional status using the Older Americans Resources and Services (OARS) Activities of Daily Living and Instrumental Activities of Daily Living (ADL/IADL) compare the difference in ADL/IADL scores before and after intervention
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Multiple Myeloma Scheduled for ASCT at UAB within 10 weeks of study enrollment age at ASCT ≥60y Exclusion Criteria: at high risk for impending pathologic fracture using Mirels score
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clare Ubersax, BS
Phone
205-638-2120
Email
clareubersax@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Tucker, MSPH
Phone
2056382120
Email
abigailtucker@uabmc.edu
Facility Information:
Facility Name
Kirklin Clinic of UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Smith Giri, Dr.
Phone
205-638-2120
Email
CAREheme@peds.uab.edu

12. IPD Sharing Statement

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Prehabilitation Feasibility Among Older Adults Undergoing Transplantation

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