UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048901 |
|---|---|
| Receipt number | 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 11:12:45 |
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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
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
iftikharalam@bkuc.edu.pk
Sponsor or person
Institute
Nutrition Education, Awareness & Training (NEAT) Pakistan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055720
