The Effect of Leisure Time Physical Activity Program on Activity Daily Living and Hope in Elderly Men
Design
A clinical trial with control and intervention groups, with parallel groups, double-blind, randomized on 60 elderly samples. Statistical software was used for randomization.
Settings and conduct
Selected park or parks with ease of access for samples
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 60 to 80 years old; absence of acute underlying disease; absence of debilitating motor problems and defects.
Exclusion criteria: acute illness and hospitalization during the study; inability to tolerate research interventions.
Intervention groups
Before starting the intervention, Barthel and Adult Hope Scale (AHS) demographic information questionnaires are completed by the researcher through a face-to-face interview with the elderly. Leisure time physical activities are performed in 8 sessions, once a week (8 weeks) and each session lasts at least 45 minutes in groups and in three groups of ten people. So that all three groups receive interventions on three different days every week. The intervention items include walking for thirty minutes, balance exercise for the elderly for fifteen minutes (including exercises: standing on one leg - standing on the toe - walking on the heel and toes - moving by sticking the heel to the big toe - walking in the figure of eight in English. Each for three minutes). The control group will receive the usual physical activities performed by themselves and the contingency plans of the respective health center. Two weeks after the end of the intervention, the mentioned questionnaires will be completed again.
Main outcome variables
Activity Daily Living; hope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230224057518N1
Registration date:2023-07-10, 1402/04/19
Registration timing:retrospective
Last update:2023-07-10, 1402/04/19
Update count:0
Registration date
2023-07-10, 1402/04/19
Registrant information
Name
Mahdi Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3662 8015
Email address
azizim982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
2023-04-21, 1402/02/01
Actual recruitment end date
2023-05-05, 1402/02/15
Trial completion date
empty
Scientific title
The Effect of Leisure-time Physical Activity Program on Activity Daily Living and Hope in the Elderly men
Public title
The Effect of Leisure-time Physical Activity Program on Activity Daily Living and Hope in the Elderly men
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 to 80 years
Living at home
Absence of acute underlying disease
Ability to communicate verbally
Not participating in similar programs
No use of drugs and alcohol
The absence of a stressful event within the last 6 months
Informed consent
Absence of disabling motor problems and defects
Absence of sensory disorders (such as vision and hearing disorders)
Exclusion criteria:
Acute illness and hospitalization during the study
Absence of more than one session
Inability to tolerate research interventions
Age
From 60 years old to 80 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of samples into two intervention and control groups using SPSS statistical software and concealment of random allocation using two sealed envelopes, which specify the control and intervention groups, and the researcher is not aware of its content before random allocation. .
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 Mashhad University of Medical Sciences, Mashhad College of Nursing and Midwifery
Street address
Faculty of Nursing and Midwifery, Doctora Crossroad, Ibn Sina St., Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-02-27, 1401/12/08
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.103
Health conditions studied
1
Description of health condition studied
Elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The degree of dependency in Activity Daily Living
Timepoint
Before the start of the intervention and two weeks after the end of the intervention
Method of measurement
Barthel Activity Daily Living Scale
2
Description
Degree of hope
Timepoint
Before the start of the intervention and two weeks after the end of the intervention
Method of measurement
Snyder Hope Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention items include walking for thirty minutes, balance training for the elderly for fifteen minutes (including exercises: standing on one leg - standing on the toe - walking on the heel and toes - moving by attaching the heel to the big toe- walking in the form of eight in English. each for three minutes). In order to facilitate the intervention, the intervention group is divided into three groups of ten people, and the mentioned interventions are performed equally for all three groups, and there is no special difference between the members of the intervention groups, nor in the interventions performed.
Category
Lifestyle
2
Description
Control group: They will receive the usual physical activities performed by themselves and the possible plans of the relevant health center. No other specific intervention in the study will be done for them.