evaluating the effects of Core Stability Exercises on Balance and Walking in Elderly Fallers with Mild Cognitive Impairment
Design
A randomized clinical trial study, single-blind, Factorial, 30 elderly randomized to intervention groups and a control group.
Settings and conduct
Participants are divided into two groups: core stability training, and control groups. This study was single-blind that the outcome assessor is blind to interventions. This study will be conducted in the neighbourhood of Tehran Municipality, District 7, and the participants will be explained the importance of protocol. The protocols are 8 weeks and three 40-minute sessions per week.
Participants/Inclusion and exclusion criteria
Had a history of falls in the last 6 month. Obtain score less than 24 on the Mini-mental state examination (MMSE). Able to walk without an Assistive Device.
Intervention groups
Intervention group: Core stability exercises - Exercises were performed for eight weeks and three sessions per week for the exercise group. The duration of each training session was 40 minutes, and each session included 5 minutes of warm-up and 5 minutes of cooling down. Core stability exercises consist of 3 levels. All exercises are under the supervision of a physiotherapist. In addition, the researcher stands close to the participant and is careful in all stages of training to prevent events such as falling. Exercises started from level 1, which included static contractions in a steady-state, level 2 exercises included static contractions in an unstable environment. Finally, level 3 exercises included dynamic movements in an unstable position.Control group: without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.
Main outcome variables
Static Balance, Dynamic Balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180627040251N3
Registration date:2020-08-19, 1399/05/29
Registration timing:retrospective
Last update:2020-08-19, 1399/05/29
Update count:0
Registration date
2020-08-19, 1399/05/29
Registrant information
Name
Hassan Sadeghi
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8001
Email address
hassan.sadeghi81@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-27, 1398/08/05
Actual recruitment start date
2019-10-07, 1398/07/15
Actual recruitment end date
2019-12-06, 1398/09/15
Trial completion date
2020-02-29, 1398/12/10
Scientific title
The Effects of Core Stability Exercises on Balance and Walking in Elderly Fallers with Mild Cognitive Impairment: A randomized control trial
Public title
Effects of Core Stability Exercises on Balance and Walking in Elderly Fallers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Had a history of falls in the last 6 month
Obtain score less than 24 on the Mini-mental state examination (MMSE) .
Able to walk without an Assistive Device.
60 years of age and older with the ability and mobility to join the group training sessions.
Exclusion criteria:
Have acute or chronic disease with influence on balance control (e.g., Parkinson’s disease; diabetes or peripheral neuropathy).
Who participated in regular exercise programs in the last 6th month.
Acute vision and hearing problems
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial evaluation, randomization was done using randomization blocks of 4 methods. Patients are randomly assigned to one of two groups through four random blocks. A member of the research team who is not involved in the selection of samples will determine the randomization sequence using an online randomization system (randomizer.org). Participants will be notified of their group allocation with a sealed envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favour of a specific therapeutic intervention.
Activity, other involving muscle strengthening exercises
Primary outcomes
1
Description
Functional Mobility
Timepoint
Before the exercise program and after exercise program
Method of measurement
Timed Up and Go test (TUG)
Secondary outcomes
1
Description
Static Balance
Timepoint
Before the exercise program and after exercise program
Method of measurement
Single leg Stance test
2
Description
Walking
Timepoint
Before the exercise program and after exercise program
Method of measurement
10 Meter walking test
Intervention groups
1
Description
Intervention group: Core stability exercises - Exercises were performed for eight weeks and three sessions per week for the exercise group. The duration of each training session was 40 minutes, and each session included 5 minutes of warm-up and 5 minutes of cooling down. Core stability exercises consist of 3 levels. All exercises are under the supervision of a physiotherapist. In addition, the researcher stands close to the participant and is careful in all stages of training to prevent events such as falling. Exercises started from level 1, which included static contractions in a steady-state, level 2 exercises included static contractions in an unstable environment. Finally, level 3 exercises included dynamic movements in an unstable position. The exercises used in this protocol, including the specific exercises to stabilize and the muscles of the spine, pelvic lumbar region, and abdomen.
Category
Rehabilitation
2
Description
Control group: without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Department of Municipality District 7
Full name of responsible person
Miss Maryam Priyaie
Street address
Gorgan Neighborhood House, Tavakoli Park, Shahid Madani St,
City
Tehran
Province
Tehran
Postal code
1615786614
Phone
+98 21 7754 0432
Email
info.region7@tehran.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr Ali Abbasi
Street address
3th floor. Faculty of sport science and Physical Education, Shahid Keshvari Sports Complex, Razan Jonobi, Mirdamad,