The effect of 8 weeks of selected hand strength training and cinnamon and honey supplementation on inflammatory biomarkers, function, and quality of life of women with hand osteoarthritis
The effect of 8 weeks of selected hand strength training and cinnamon and honey supplementation on inflammatory biomarkers, function and quality of life in women with osteoarthritis of the hand
Design
This clinical trial design was randomized as a parallel design, with the control group, and is non -blinded one. In this randomized study, phases 2-3 will be performed on 48 patients with hand osteoarthritis . A random number table is used for randomization and participants are assigned to four intervention and control groups (three intervention groups and one control group).
Settings and conduct
This study, which will be conducted in Imam Reza Hospital of Kermanshah, is a non-blinded one. At the beginning of the study, a quality of life questionnaire will be provided for patients. At the end of the study, the quality of life questionnaire is given to patients again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; women with hand osteoarthritis
Women over 60 years
Exclusion criteria: Women with cancer; Women with mental disorders
Intervention groups
The first intervention group will undergo selected strength training for 8 weeks. The second intervention group will use the honey supplement and cinnamon powder twice a day for 8 weeks. The third intervention group will undergo simultaneous hand exercises (8 weeks) and use of the honey supplement and cinnamon powder (8 weeks twice a day). The control group will not receive any intervention.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N173
Registration date:2021-08-07, 1400/05/16
Registration timing:retrospective
Last update:2021-08-07, 1400/05/16
Update count:0
Registration date
2021-08-07, 1400/05/16
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-02, 1398/02/12
Expected recruitment end date
2019-07-03, 1398/04/12
Actual recruitment start date
2019-05-02, 1398/02/12
Actual recruitment end date
2019-07-03, 1398/04/12
Trial completion date
2019-07-06, 1398/04/15
Scientific title
The effect of 8 weeks of selected hand strength training and cinnamon and honey supplementation on inflammatory biomarkers, function, and quality of life of women with hand osteoarthritis
Public title
The effect of 8 weeks of selected hand strength training and cinnamon and honey supplementation on inflammatory biomarkers, function, and quality of life of women with hand osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
women with hand osteoarthritis
Women over 60 years
Exclusion criteria:
Women with cancer
Women with mental disorders
Age
From 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method. 48 cards with numbers from 1 to 48 are placed in the envelope. 12 cards that are randomly selected in the first stage are assigned to the first group. 12 cards that are randomly selected in the second stage are assigned to the second group, 12 cards that are randomly selected in the third stage are assigned to the the third group, the remaining 12 cards are assigned to the fourth group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-08-06, 1398/05/15
Ethics committee reference number
IR.KUMS.REC.1398.548
Health conditions studied
1
Description of health condition studied
Hand Osteoarthritis
ICD-10 code
M19.049
ICD-10 code description
Primary osteoarthritis, unspecified hand
Primary outcomes
1
Description
Quality of Life
Timepoint
Start of study and end of study (8 weeks later)
Method of measurement
Using Quality of Life Questionnaire (SF36)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will undergo selected strength training for 8 weeks every day (Daily with 10 repetitions during weeks one to two, 12 repetitions in weeks three to four and 15 repetitions in weeks five to eight)
Category
Treatment - Other
2
Description
The second intervention group will use the honey supplement and cinnamon powder once a day for 8 weeks
Category
Treatment - Other
3
Description
The third intervention group will undergo simultaneous hand exercises for 8 weeks every day (Daily with 10 repetitions during weeks one to two, 12 repetitions in weeks three to four, and 15 repetitions in weeks five to eight) and use the honey supplement and cinnamon powder (8 weeks once a day).
Category
Treatment - Other
4
Description
The control group will not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Shayesteh Hasani
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
hassani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Arash Bochani
Street address
Vice Chancellor for Research and Technology, Islamic Azad University, Kasra St
City
Kermanshah
Province
Kermanshah
Postal code
6718997551
Phone
+98 83 3724 3181
Email
a.bochani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Sedigheh Hosainpoor Delavar
Position
Faculty member of Kermanshah Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Kasra St., Islamic Azad University
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۸۹۹۷۵۵۱
Phone
0098833724317
Email
Hosainpoordelavar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Sedigheh Hosainpoor Delavar
Position
Faculty member of Islamic Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Kasra St., Islamic Azad University
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۸۹۹۷۵۵۱
Phone
0098833724317
Email
Hosainpoordelavar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Sedigheh Hosainpoor Delavar
Position
Faculty member of Islamic Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Kasra St., Islamic Azad University
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۸۹۹۷۵۵۱
Phone
+98 83 3724 3181
Email
Hosainpoordelavar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD