UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048339 |
|---|---|
| Receipt number | R000024171 |
| Scientific Title | The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases. |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2022/07/12 09:01:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases.
Acronym
The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases.
Scientific Title
The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases.
Scientific Title:Acronym
The study on the effects of outpatient rehabilitation in HIV-infected middle-aged and elderly hemophilia cases.
Region
| Japan |
Condition
Condition
hemophilia
HIV
Classification by specialty
| Infectious disease | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the effects of physical therapy in hemophilia patients by comparing the effects of home exercise with versus without once-monthly physical therapy delivered by a physical therapist for 6 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
*Range of Motion
*Muscle strength
*10-m walking
Key secondary outcomes
cadence, stride length
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*Person who has obtained written consent
*Persons diagnosed with HIV-infected hemophilia
*Persons who can evaluate range of motion, muscle strength, and 10m walking
Key exclusion criteria
*Persons with hemorrhagic arthropathy, intra-articular bleeding, intramuscular bleeding, and fractures that have not healed on the day of evaluation
*Persons judged by the principal investigator to be inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Fujitani |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
1-21-1, toyama, shinjuku-ku, Tokyo
TEL
03-3202-7181
jufujita@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Kikuchi |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
1-21-1, toyama, shinjuku-ku, Tokyo
TEL
0332027181
Homepage URL
jufujita@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1, toyama, shinjuku-ku, Tokyo
Tel
0332027181
rinrijm@hosp.ncgm.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立国際医療研究センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.ghmopen.com/
Publication of results
Published
Result
URL related to results and publications
https://www.ghmopen.com/
Number of participants that the trial has enrolled
18
Results
There were 11 people in the physical therapy precedent group (average age 51.9 years) and 7 people in the Home exercise precedent group (average age 53.3 years).
The carryover effect was in the right hip flexion muscle strength and fast walking rate. The Period effect was in the left hip extension range, right ankle dorsiflexion range, and fast walking rate.
Results date posted
| 2022 | Year | 07 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
patients with hemophilia infected with human immunodeficiency virus(HIV)
Participant flow
Participants were divided into 2 groups by the envelope method, and an unblinded crossover study was conducted. One group was the physical therapy-preceding group, and the other was the home exercise-preceding group. Both groups underwent initial evaluation, and the physical therapy-preceding group received physical therapy under the advice and supervision of a physical therapist once a month during a 6-month home exercise period. After completing the 6-month exercise period, a mid-term evaluation was then conducted, and the participants performed home exercises by referring to a leaflet explaining the home exercise method without intervention by a physical therapist for the following 6 months. A final evaluation was conducted at the end of the 6-month home exercise period.
In the home exercise-preceding group, after the initial evaluation, participants carried out home exercises without monthly intervention by a physical therapist for 6 months by referring to the abovementioned leaflet. After this 6-month exercise period, a mid-term evaluation was conducted. Thereafter, the participants received physical therapy in the same way as the physical therapy-preceding group did initially for 6 months, and at the end of this second 6-month period, a final evaluation was conducted.
Adverse events
none
Outcome measures
Evaluation items were range of motion, muscle strength, and 10m walking. Muscle strength was evaluated using a handheld dynamometer. In 10m walking, participants were instructed to walk at two speeds, normal and fast walking, and the speed, cadence, and stride length were analyzed.
Plan to share IPD
under consideration
IPD sharing Plan description
under consideration
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
cross-over observational study
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024171
