Prehabilitation Feasibility Among Older Adults Undergoing Transplantation

Multiple Myeloma Clinical Trial

Official title:

Feasibility of a Prehabilitation Intervention Among Older Adults With Myeloma Receiving Autologous Stem Cell Transplant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642884
• Other study ID #: UAB 2281
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: Clare Ubersax, BS
• Phone: 205-638-2120
• Email: clareubersax[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Other:
• Multi-modal Exercise Regimen
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.

Behavioral:
• Dietary Guidelines
Participants will be contacted once a week to review dietary recommendations per the 2022 American Cancer Society guidelines for cancer survivors.

Locations

Country	Name	City	State
United States	Kirklin Clinic of UAB Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Smith Giri

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Primary	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.	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year