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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05642884
Other study ID # UAB 2281
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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