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

GVHD,Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05401955
• Other study ID #: Interventional
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: May 2022
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 30, 2023
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Allogenic Transplantation patients with Graft versus host disease

Exclusion Criteria:

• Cognitive impairment
• Physical limitation from other pathologies

Related Conditions & MeSH terms

• Graft vs Host Disease
• GVHD, Chronic
• GVHD,Acute

Intervention

Other:
• Physical exercise
An adapted physical exercise protocol

Locations

Country	Name	City	State
Spain	University of Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF36 Questionnaire	Quality of life	baseline and post-intervention (24 weeks)
Primary	2 minutes walk test	walking for 2 minutes without rest	baseline and post-intervention (24 weeks)
Primary	Hands strength	Dynamometer	baseline and post-intervention (24 weeks)
Primary	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)