Physiotherapy and Therapeutic Exercise Program in Graft-v... | NCT05401955

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

NCT05401955

Sponsor

University of Salamanca

Status

Unknown status

Last Update Posted

Jun 2, 2022Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

GVHD,Acute
GVHD, Chronic

Interventions

Physical exercise

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

May 10, 2022Actual

Completion Date

Jul 30, 2023Estimated

First Submitted Date

May 12, 2022

First Submission Date that Met QC Criteria

May 27, 2022

First Posted Date

Jun 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2022

Last Update Posted Date

Jun 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vicente Rodríguez Pérez, Associate Professor, University of SalamancaPrincipal Investigator

Lead Sponsor

University of SalamancaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Graft versus host disease Group	Experimental		Other: Physical exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical exercise	Other	An adapted physical exercise protocol	Graft versus host disease Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Allogenic Transplantation patients with Graft versus host disease

Exclusion Criteria:

Cognitive impairment
Physical limitation from other pathologies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Salamanca	Recruiting	Salamanca		37007	Spain

Condition Browse Module

MeSH Terms

ID	Term
D000092122	Bronchiolitis Obliterans Syndrome

Ancestor Terms

ID	Term
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis
D001991	Bronchitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided