NCT04552912

Brief Summary

The purpose of this study is to test the efficacy of an evidence-based tailored physical activity program adapted for adults with acute leukemia. Implementation-related process evaluation of the physical activity program will also be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

September 23, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

September 4, 2020

Last Update Submit

September 22, 2022

Conditions

Physical ActivityExerciseAcute LeukemiaConsolidationMaintenance Therapy

Outcome Measures

Primary Outcomes (2)

  • Physical Function- Short Physical Performance Battery Protocol

    Measured via evaluation on Chair Stand Test (up to 4 points), Gait Speed Test (up to 4 points) and the 4 Test Balance Scale (up to 4 points) scores can range from 0-12 points. Higher scores = better physical function

    12-weeks

  • Physical Function- 6 Minute walk test

    The 6 minute walk Test measures an individuals ability to walk in meters for 6 minutes. The distance walk in meters is recorded. Higher meter = better physical function

    12-weeks

Secondary Outcomes (5)

  • Patient-Reported Outcomes- Cognition

    12-weeks

  • Patient-Reported Outcomes-Fatigue

    12-weeks

  • Patient-Reported Outcomes-Disturbed Sleep

    12-weeks

  • Patient-Reported Outcomes-Anxiety

    12-weeks

  • Patient-Reported Outcomes-Depression

    12-weeks

Study Arms (2)

Build Stamina Group

EXPERIMENTAL

The Build StaMINA (Biobehavioral Self-Management INtervention using physical Activity) is a tailored evidence-based physical activity (PA) program designed to improve endurance, strength, and balance which are all areas of physical function, that adults with acute leukemia (AL) post-induction are known to have diminished capacity. The Build StaMINA program will be tailored to their current Physical Function, per assessment. The detailed PA prescription includes each exercise in the program as well as the frequency, number of repetitions each day and rate of perceived exertion (RPE) for each exercise. The repetitions and RPE are based on the participants' current Physical Function Assessment and will be assigned based on our evidence-based algorithm.

Behavioral: Build Stamina Program

Attention-Control Group

NO INTERVENTION

Participants assigned to the attention control group will have a Physical Function Assessment at baseline after informed consent has been provided and prior to randomization. Participants will also be asked to complete questionnaires regarding at baseline, 6-weeks and 3 months. Those in the attention-control group will also receive a newsletter detailing the benefits of participating in regular PA as well as regular phone calls by study team to discuss general health and wellbeing at the same schedule as intervention group.

Interventions

Build Stamina ProgramBEHAVIORAL

Build StaMINA intervention is a self-management intervention that provides information, motivation, behavioral skills to engage in PA, and ultimately a tailored PA program for adults with AL who are receiving consolidation/maintenance chemotherapy.

Build Stamina Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • Diagnosed with either acute leukemia
  • Receiving either maintenance or consolidation chemotherapy
  • Able to walk independently for 4 meters with or without gait aid.

You may not qualify if:

  • non-English speaking
  • receiving induction chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Tara A Albrecht, PhD, ACNP-BC, ACNP-BC, ACHPN

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 17, 2020

Study Start

January 15, 2021

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

September 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)