NCT05401955

Brief Summary

Range of motion, antropometric measurements, quality of life questionnaire and 2 minutes walk test will be implemented as an initial assessment. Physical exercise program will take 2 sessions a week for six months, and several follow-ups: before, during and after treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 1, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

9 days

First QC Date

May 12, 2022

Last Update Submit

May 27, 2022

Conditions

GVHD,AcuteGVHD, Chronic

Outcome Measures

Primary Outcomes (4)

  • SF36 Questionnaire

    Quality of life

    baseline and post-intervention (24 weeks)

  • 2 minutes walk test

    walking for 2 minutes without rest

    baseline and post-intervention (24 weeks)

  • Hands strength

    Dynamometer

    baseline and post-intervention (24 weeks)

  • Active range of motion

    P-ROM. Active ROM will be compared with standard pictures (1-4 points for lower limb and 1-7 points for upper limb)

    baseline and post-intervention (24 weeks)

Study Arms (1)

Graft versus host disease Group

EXPERIMENTAL
Other: Physical exercise

Interventions

Physical exerciseOTHER

An adapted physical exercise protocol

Graft versus host disease Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Allogenic Transplantation patients with Graft versus host disease

You may not qualify if:

  • Cognitive impairment
  • Physical limitation from other pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salamanca

Salamanca, 37007, Spain

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 12, 2022

First Posted

June 2, 2022

Study Start

May 1, 2022

Primary Completion

May 10, 2022

Study Completion

July 30, 2023

Last Updated

June 2, 2022

Record last verified: 2022-05

Locations

ES(1)