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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048901
Receipt No. R000055720
Scientific Title Physical Activity in elderly and its health effects
Date of disclosure of the study information 2022/09/15
Last modified on 2022/09/10

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Basic information
Public title Improvement in Cardio-metabolic Health and Immune Signatures in Old Individuals Using Daily Chores (Salat) as an Intervention: A Randomized
Crossover Study in a Little-studied Population
Acronym Single Centered Cross-over Control Trial
Scientific Title Physical Activity in elderly and its health effects
Scientific Title:Acronym Physical Activity in elderly and its health effects
Region
Asia(except Japan)

Condition
Condition No
Classification by specialty
Geriatrics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether moderate physical activity in the form of daily house chore activities like Salat can improve the cardio-vascular health and immune signatures in eledrly
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body Weight
Key secondary outcomes Blood lipid profile
Selected Immune Signatures
Blood Pressure
Body Fat

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 [1] Salat (a type of physical activity) done before taking meals
[2] Observation
[3] Washout 2 weeks
[4] Salat (a type of physical activity) done after taking meals
[5] Observation
Interventions/Control_2 [1] Salat (a type of physical activity) done after taking meals
[2] Observation
[3] Washout 2 weeks
[4] Salat (a type of physical activity) done before taking meals
[5] Observation
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male
Key inclusion criteria [1] Otherwise medically fit but overweight
[2] (BMI: 26-29)
[3] Age 40-80 years
[4] non-hypertensive
[5] non-diabetic
[6] male
Key exclusion criteria [1] any physical comorbidity that would have required them to offer Salat in sitting position only or on chair were excluded
[2] not habitual to offer Salat
[3] very physically active
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Iftikhar
Middle name
Last name Alam
Organization Bacha Khan University Charsadda, KP, Pakistan
Division name Human Nutrition and Dietetics
Zip code 25000
Address Bacha Khan University Charsadda, Khyber Pakhtunkhwa Province, Pakistan 25000
TEL 00923455104041
Email iftikharalam@bkuc.edu.pk

Public contact
Name of contact person
1st name Iftikhar
Middle name
Last name Alam
Organization Bacha Khan University Charsadda, KP, Pakistan
Division name Human Nutrition and Dietetics
Zip code 25000
Address Bacha Khan University Charsadda, Khyber Pakhtunkhwa Province, Pakistan 25000
TEL 00923455104041
Homepage URL
Email iftikharalam@bkuc.edu.pk

Sponsor
Institute Nutrition Education, Awareness & Training (NEAT) Pakistan
Institute
Department

Funding Source
Organization Self Funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Research Ethics Committee of NEAT approved the study (NEAT/R.21/2020)
Address NEAT, Charsadda, Khyber Pakhtoonkhwa (KPK), Pakistan
Tel 00923111992285
Email dr.qazinoor@gmail.com

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

Other administrative information
Date of disclosure of the study information
2022 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2021 Year 12 Month 01 Day
Date of IRB
2021 Year 12 Month 01 Day
Anticipated trial start date
2021 Year 12 Month 10 Day
Last follow-up date
2022 Year 02 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 09 Month 10 Day
Last modified on
2022 Year 09 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055720

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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