UMIN-CTR Clinical Trial

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