Physiotherapy and Therapeutic Exercise Program in Graft-versus-host Disease (GvHD)

May 27, 2022 updated by: Vicente Rodríguez Pérez, University of Salamanca

Effects of a Physical Therapy and Therapeutic Exercise Program in Graft-versus-host Disease (GVHD)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37007
        • Recruiting
        • University of Salamanca
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Allogenic Transplantation patients with Graft versus host disease

Exclusion Criteria:

  • Cognitive impairment
  • Physical limitation from other pathologies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Graft versus host disease Group
Other: Physical exercise
An adapted physical exercise protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF36 Questionnaire
Time Frame: baseline and post-intervention (24 weeks)
Quality of life
baseline and post-intervention (24 weeks)
2 minutes walk test
Time Frame: baseline and post-intervention (24 weeks)
walking for 2 minutes without rest
baseline and post-intervention (24 weeks)
Hands strength
Time Frame: baseline and post-intervention (24 weeks)
Dynamometer
baseline and post-intervention (24 weeks)
Active range of motion
Time Frame: baseline and post-intervention (24 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

May 10, 2022

Study Completion (Anticipated)

July 30, 2023

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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