NCT07581093

Brief Summary

A prospective, longitudinal cohort study will be conducted to evaluate the effects of treatment on the physical function of patients undergoing Allogeneic Hematopoeitic Stem Cell Transplant.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
44mo left

Started May 2026

Typical duration for all trials

Status
not yet recruiting

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

Study Progress2%
May 2026Dec 2029

First Submitted

Initial submission to the registry

March 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2029

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

3.7 years

First QC Date

March 26, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

Stem Cell TransplantationPhysical Functional PerformancePhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Change in Physical Function

    The Short Physical Performance Battery will be used to assess physical function. Scores range from 0 to 12, with higher scores indicating better physical performance and functional mobility.

    Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).

  • Change in Physical Function

    The World Health Organization Disability Schedule 2.0 will be used to assess any change in health and disability. A 12-item version will be used with each item rated on a 5-point Likert scale Higher scores indicate greater disability ie. minimum: 12 (no disability) and maximum: 60 (complete/extreme disability)

    Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).

Secondary Outcomes (9)

  • Change in Aerobic Fitness

    Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).

  • Change in Muscle Strength

    Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).

  • Change in Physical Activity Levels

    Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).

  • Change in Quality of Life

    Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).

  • Change in Fatigue Levels

    Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).

  • +4 more secondary outcomes

Other Outcomes (1)

  • Qualitative Feedback

    Pre-treatment (T0), Pre-admission (T1), 3 months post-transplant (T2), 6 months post-transplant (T3), 1 year post-transplant assessment (T4).

Study Arms (1)

Patients undergoing haematopoeitic stem cell transplant

Patients who are listed for allogeneic stem cell transplant.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing allogeneic stem cell transplant.

You may qualify if:

  • Patients who are listed for allogeneic stem cell transplant.
  • Ability to provide written informed consent
  • Over 18 years old

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Grainne Sheill, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 26, 2026

First Posted

May 12, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 28, 2029

Study Completion (Estimated)

December 28, 2029

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share