Effect of individualized exercise interventions versus control group on musculoskeletal disorders and quality of life in Parkinson's patients: a randomized clinical trial
To assess the effect of individualized exercise interventions versus control group on musculoskeletal disorders and quality of life in Parkinson's patients
Design
This is a Phase III non-blind randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Sina Hospital in Hamadan city, involving 42 eligible patients with Parkinson. The patients will be randomly assigned to the intervention and control groups through the block randomization/drawing of lots. It should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 30 to 65 years
Parkinson's with mild to moderate functioning
Exclusion criteria:
Inability to do sports
Intervention groups
Intervention group:
Routine treatment plus the American College of Sports Medicine (ACSM) exercise protocol is given at home using a formula (Frequency, Intensity, Time, and Type) specific to each patient based on conditions including low back pain, lordosis, and scoliosis. The exercise protocol includes isometric activities in the morning, noon and night three times a week for 12 weeks.
Control group:
Routine treatment
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of individualized exercise interventions versus control group on musculoskeletal disorders and quality of life in Parkinson's patients: a randomized clinical trial
Public title
Effect of individualized exercise interventions versus control group on musculoskeletal disorders and quality of life in Parkinson's patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 65 years
Parkinson's with mild to moderate functioning
Exclusion criteria:
Inability to do sports
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-06-27, 1402/04/06
Ethics committee reference number
IR.UMSHA.REC.1402.424
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Musculoskeletal disorders
Timepoint
Before the intervention and 12 weeks later
Method of measurement
Using the Nordic questionnaire
2
Description
Quality of life
Timepoint
Before the intervention and 12 weeks later
Method of measurement
Using the World Health Organization Quality of Life Summary Questionnaire (WHOQOL-BREF)
3
Description
Cognitive performance
Timepoint
Before the intervention and 12 weeks later
Method of measurement
Using MoCA questionnaire
4
Description
Parkinson's severity
Timepoint
Before the intervention and 12 weeks later
Method of measurement
Using the Unified Parkinson's disease rating scale (UPDRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus the American College of Sports Medicine (ACSM) exercise protocol is given at home using a formula (Frequency, Intensity, Time, and Type) specific to each patient based on conditions including low back pain, lordosis, and scoliosis. The exercise protocol includes isometric activities in the morning, noon and night three times a week for 12 weeks.
Category
Other
2
Description
Control group: Routine treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Motahare Bagheri
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
motahare.bgr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Motahare Bagheri
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
motahare.bgr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Rashid Heidari Moghadam
Position
Sports Medicine Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
haydarimoghadam@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available