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

• Sponsor: University of Salamanca (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05401955
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
GVHD,Acute; GVHD, Chronic	Other: Physical exercise	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effects of a Physical Therapy and Therapeutic Exercise Program in Graft-versus-host Disease (GVHD)
• Actual Study Start Date: May 1, 2022
• Actual Primary Completion Date: May 10, 2022
• Anticipated Study Completion Date: Jul 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. SF36 Questionnaire [baseline and post-intervention (24 weeks)]

   Quality of life

2. 2 minutes walk test [baseline and post-intervention (24 weeks)]

   walking for 2 minutes without rest

3. Hands strength [baseline and post-intervention (24 weeks)]

   Dynamometer

4. Active range of motion [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Allogenic Transplantation patients with Graft versus host disease

Exclusion Criteria:

• Cognitive impairment

• Physical limitation from other pathologies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Salamanca	Salamanca		Spain	37007

Sponsors and Collaborators

• University of Salamanca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vicente Rodríguez Pérez, Associate Professor, University of Salamanca
• ClinicalTrials.gov Identifier: NCT05401955
• Other Study ID Numbers: Interventional
• First Posted: Jun 2, 2022
• Last Update Posted: Jun 2, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of Jun 2, 2022