Back to resultsPhysiotherapy and Therapeutic Exercise Program in Graft-versus-host Disease (GvHD)
Primary Purpose
GVHD,Acute, GVHD, Chronic
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
About this trial
This is an interventional supportive care trial for GVHD,Acute
Eligibility Criteria
Inclusion Criteria:
- Allogenic Transplantation patients with Graft versus host disease
Exclusion Criteria:
- Cognitive impairment
- Physical limitation from other pathologies
Sites / Locations
- University of SalamancaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Graft versus host disease Group
Arm Description
Outcomes
Primary Outcome Measures
SF36 Questionnaire
Quality of life
2 minutes walk test
walking for 2 minutes without rest
Hands strength
Dynamometer
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05401955
Brief Title
Physiotherapy and Therapeutic Exercise Program in Graft-versus-host Disease (GvHD)
Official Title
Effects of a Physical Therapy and Therapeutic Exercise Program in Graft-versus-host Disease (GVHD)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GVHD,Acute, GVHD, Chronic
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Graft versus host disease Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
An adapted physical exercise protocol
Primary Outcome Measure Information:
Title
SF36 Questionnaire
Description
Quality of life
Time Frame
baseline and post-intervention (24 weeks)
Title
2 minutes walk test
Description
walking for 2 minutes without rest
Time Frame
baseline and post-intervention (24 weeks)
Title
Hands strength
Description
Dynamometer
Time Frame
baseline and post-intervention (24 weeks)
Title
Active range of motion
Description
P-ROM. Active ROM will be compared with standard pictures (1-4 points for lower limb and 1-7 points for upper limb)
Time Frame
baseline and post-intervention (24 weeks)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Allogenic Transplantation patients with Graft versus host disease
Exclusion Criteria:
Cognitive impairment
Physical limitation from other pathologies
Facility Information:
Facility Name
University of Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Rodríguez, Ph.D.
Phone
+34923294590
Ext
3162
Email
vicente.rodriguez@usal.es
12. IPD Sharing Statement
Learn more about this trial
Physiotherapy and Therapeutic Exercise Program in Graft-versus-host Disease (GvHD)
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