Elderly CareNCT05098496
Normative Values of Functional Fitness in Elderly Population
An observational study of Elderly Care and Functional Fitness, run by Riphah International University at 1 site in Pakistan.
Trial summary
Frailty is a multidimensional concept that influences several domains , such as body mass decline, gait ,mobility, balance ,muscle strength ,motor processing ,cognition, nutrition endurance, and physical activity, and its directly related to adverse consequences such as falls ,disability the need for long term care … Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Elderly Care, Functional Fitness
- How many people
- 500 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2021to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Informed consent will be obtained from participants to meet inclusion criteria before including in study.It is a cross sectional study, researcher will find out the normative values of senior citizen by using senior fitness test SFT in both male and female gender 60 or above age .Senior fitness test contains 6 six and before assessment , screening participants either meet inclusion criteria or not and for basic and advanced everyday activities . Anthropometric measurements by BMI body mass index will used. So overall this procedure will contain 45 to 50 minute per participant. All readings of SFT 6 components will be mentioned in table according to gender and age group 60-64yrs ,65-69yrs,70-74yrs,75-79yrs,80-84yrs
Who may be able to join
- Subjects 60 years and above,living independently (not community dwelling, hospitals, nurse homes etc ), moving and performing daily activities independently
- No medical contraindications to participate in physical fitness tests, with no problems in terms of verbal communication, no physical and cognitive restrictions
Who cannot join
- If Participants have any medical contraindications for physical activity programs and to hold medical insurance.
- Cormobidites ,disability, any cardiac or pulmonary dysfunction (COPD, exercise related exertion etc).
- Physical condition hindering anthropometric examination (such as immobile patients, contraindication to lifting or amputation of both lower extremities).
Trial locations and contacts
1 site in 1 country.
About this study
Frailty is a multidimensional concept that influences several domains , such as body mass decline, gait ,mobility, balance ,muscle strength ,motor processing ,cognition, nutrition endurance, and physical activity, and its directly related to adverse consequences such as falls ,disability the need for long term care , hospitalization and even mortality. As the elderly have twice as many disabilities and four times as many physical limitations as people less than 60 years of age. There is a need to focus on this demographic shift and Aging population Pakistan increasing double in 2050 hence is has become a new challenge. So, Effective approaches is needed to help older people maintain a healthy and active life. The main objective is to determine reference values of senior fitness test SFT for elderly population. The Senior Fitness Test is a battery of tests for the assessment of the functional fitness of older persons. This test will assess the physiological capacity for carrying out normal daily activities independently and safely without the appearance of fatigue. For this study cross sectional survey will conduct and will use non probability convenience sampling technique , sample size will be 500 both male and female and conducted from Heaven old age homes and Dar ul Khilafa old age home, Lahore. Inclusion criteria includes subject 60 and above , living Subjects 60 years and above, living independently (not community dwelling, hospitals, nurse homes etc ), perform ADLS. Exclusion criteria includes if not willing to participate, any medical contraindication, unable to speech ,functional disability .All the analysis will be carried out on SPSS v -25.
Read the detailed description
According to the world health organization WHO, the proportion of older people above 60 is growing more rapidly than any other age group. Within this group not everyone reach old age successfully. Although the common rule is that increasing age is related to decreasing well-being and increasing levels of frailty. It is also true that individual with same chronological age can vary in health and functional status . Functional fitness is a way to help people perform daily tasks with ease. It includes exercises that mimic the movements of daily activities. Walking, squatting, bending, pushing, and pulling are examples. Three key elements of functional fitness for seniors are balance, mobility, and strength. Improving these three aspects of physical fitness helps seniors: Maintain a healthy body weight, Reduce the risk of falling, Make activities of daily living easier, Boost emotional health. The discovery of effective interventions to prevent or delay disability in older persons is a public health priority. The geriatric assessment designed to manage frail older people requiring medical care, is responsible for early diagnosis , assessment, treatment, and planning while addressing a person's medical, psychological, social, and functional capabilities.
The purpose of study to highlights age-related differences in physical abilities and the risk for the loss of independence in later life. High walkability of the living environment provides opportunities for physical activity in old age, but among those with physical limitations especially, awareness of environmental facilitators may be needed to promote physical activity. The main objective of this research will be to provide normative values of functional fitness in 60 and above seniors citizens of Pakistan .Research results will enable preparing an effective intervention strategy for maintaining mobility and functional independence of elderly people.
- Conditions
- Elderly Care, Functional Fitness
- Keywords
- Normative values, Senior Fitness Test, Functional fitness
What is being measured
The primary outcome is the main question the study is designed to answer.
Senior Fitness Test
Functional fitness will be assessed by using the SFT battery includes; 30-Second Chair Stand Test - lower body strength, Arm Curl Test - upper body strength assessment, Chair Sit and-Reach Test - assessment of the flexibility of the lower body, Back Scratch Test - assessment of the flexibility of the upper body, 8-Foot Up-and-Go Test - agility and dynamic balance assessment, 6 - Minute Walk Test - aerobic endurance rating
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Apr 2021
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Elderly CareStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danish Hassan, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098496
- Sponsor's protocol ID
- RiphahIU Ayesha Akbar
- Status last verified
- Apr 2022
- First submitted
- 20 Aug 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naz L, Ghimire U, Zainab A. Behavioral factors associated with utilization of healthcare services among elderly in Pakistan: evidence from a nationally representative survey. BMC Geriatr. 2021 Jan 12;21(1):42. doi: 10.1186/s12877-021-02005-3.
PubMed 33435874Sabzwari SR, Iqbal R, Fatmi Z, Azam I. Factors associated with geriatric morbidity and impairment in a megacity of Pakistan. PLoS One. 2019 Jun 27;14(6):e0218872. doi: 10.1371/journal.pone.0218872. eCollection 2019.
PubMed 31247025Clark PG, Blissmer BJ, Greene GW, Lees FD, Riebe DA, Stamm KE. Maintaining exercise and healthful eating in older adults: the SENIOR project II: study design and methodology. Contemp Clin Trials. 2011 Jan;32(1):129-39. doi: 10.1016/j.cct.2010.10.002. Epub 2010 Oct 16.
PubMed 20955821Chen B, Shin S. Bibliometric Analysis on Research Trend of Accidental Falls in Older Adults by Using Citespace-Focused on Web of Science Core Collection (2010-2020). Int J Environ Res Public Health. 2021 Feb 9;18(4):1663. doi: 10.3390/ijerph18041663.
PubMed 33572483Ortega FB, Cadenas-Sanchez C, Lee DC, Ruiz JR, Blair SN, Sui X. Fitness and Fatness as Health Markers through the Lifespan: An Overview of Current Knowledge. Prog Prev Med (N Y). 2018 Apr 2;3(2):e0013. doi: 10.1097/pp9.0000000000000013. eCollection 2018 Apr.
PubMed 32671316
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Values of Functional Fitness in Elderly Population
- ClinicalTrials.gov ID
- NCT05098496
- Acronym / sponsor ID
- RiphahIU Ayesha Akbar
- Conditions
- Elderly Care, Functional Fitness
- Keywords
- Normative values, Senior Fitness Test, Functional fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frailty is a multidimensional concept that influences several domains , such as body mass decline, gait ,mobility, balance ,muscle strength ,motor processing ,cognition, nutrition endurance, and physical activity, and its directly related to adverse consequences such as falls ,disability the need for long term care , hospitalization and even mortality. As the elderly have twice as many disabilities and four times as many physical limitations as people less than 60 years of age. There is a need to focus on this demographic shift and Aging population Pakistan increasing double in 2050 hence is has become a new challenge. So, Effective approaches is needed to help older people maintain a healthy and active life. The main objective is to determine reference values of senior fitness test SFT for elderly population. The Senior Fitness Test is a battery of tests for the assessment of the functional fitness of older persons. This test will assess the physiological capacity for carrying out normal daily activities independently and safely without the appearance of fatigue. For this study cross sectional survey will conduct and will use non probability convenience sampling technique , sample size will be 500 both male and female and conducted from Heaven old age homes and Dar ul Khilafa old age home, Lahore. Inclusion criteria includes subject 60 and above , living Subjects 60 years and above, living independently (not community dwelling, hospitals, nurse homes etc ), perform ADLS. Exclusion criteria includes if not willing to participate, any medical contraindication, unable to speech ,functional disability .All the analysis will be carried out on SPSS v -25.
Detailed description
According to the world health organization WHO, the proportion of older people above 60 is growing more rapidly than any other age group. Within this group not everyone reach old age successfully. Although the common rule is that increasing age is related to decreasing well-being and increasing levels of frailty. It is also true that individual with same chronological age can vary in health and functional status . Functional fitness is a way to help people perform daily tasks with ease. It includes exercises that mimic the movements of daily activities. Walking, squatting, bending, pushing, and pulling are examples. Three key elements of functional fitness for seniors are balance, mobility, and strength. Improving these three aspects of physical fitness helps seniors: Maintain a healthy body weight, Reduce the risk of falling, Make activities of daily living easier, Boost emotional health. The discovery of effective interventions to prevent or delay disability in older persons is a public health priority. The geriatric assessment designed to manage frail older people requiring medical care, is responsible for early diagnosis , assessment, treatment, and planning while addressing a person's medical, psychological, social, and functional capabilities.
The purpose of study to highlights age-related differences in physical abilities and the risk for the loss of independence in later life. High walkability of the living environment provides opportunities for physical activity in old age, but among those with physical limitations especially, awareness of environmental facilitators may be needed to promote physical activity. The main objective of this research will be to provide normative values of functional fitness in 60 and above seniors citizens of Pakistan .Research results will enable preparing an effective intervention strategy for maintaining mobility and functional independence of elderly people.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Informed consent will be obtained from participants to meet inclusion criteria before including in study.It is a cross sectional study, researcher will find out the normative values of senior citizen by using senior fitness test SFT in both male and female gender 60 or above age .Senior fitness test contains 6 six and before assessment , screening participants either meet inclusion criteria or not and for basic and advanced everyday activities . Anthropometric measurements by BMI body mass index will used. So overall this procedure will contain 45 to 50 minute per participant. All readings of SFT 6 components will be mentioned in table according to gender and age group 60-64yrs ,65-69yrs,70-74yrs,75-79yrs,80-84yrs
Key inclusion criteria (2 listed)
- Subjects 60 years and above,living independently (not community dwelling, hospitals, nurse homes etc ), moving and performing daily activities independently
- No medical contraindications to participate in physical fitness tests, with no problems in terms of verbal communication, no physical and cognitive restrictions
Key exclusion criteria (3 listed)
- If Participants have any medical contraindications for physical activity programs and to hold medical insurance.
- Cormobidites ,disability, any cardiac or pulmonary dysfunction (COPD, exercise related exertion etc).
- Physical condition hindering anthropometric examination (such as immobile patients, contraindication to lifting or amputation of both lower extremities).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Senior Fitness Test
Time frame: Day 1
Functional fitness will be assessed by using the SFT battery includes; 30-Second Chair Stand Test - lower body strength, Arm Curl Test - upper body strength assessment, Chair Sit and-Reach Test - assessment of the flexibility of the lower body, Back Scratch Test - assessment of the flexibility of the upper body, 8-Foot Up-and-Go Test - agility and dynamic balance assessment, 6 - Minute Walk Test - aerobic endurance rating
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 33435874Naz L, Ghimire U, Zainab A. Behavioral factors associated with utilization of healthcare services among elderly in Pakistan: evidence from a nationally representative survey. BMC Geriatr. 2021 Jan 12;21(1):42. doi: 10.1186/s12877-021-02005-3.
- Background: PubMed 31247025Sabzwari SR, Iqbal R, Fatmi Z, Azam I. Factors associated with geriatric morbidity and impairment in a megacity of Pakistan. PLoS One. 2019 Jun 27;14(6):e0218872. doi: 10.1371/journal.pone.0218872. eCollection 2019.
- Background: PubMed 20955821Clark PG, Blissmer BJ, Greene GW, Lees FD, Riebe DA, Stamm KE. Maintaining exercise and healthful eating in older adults: the SENIOR project II: study design and methodology. Contemp Clin Trials. 2011 Jan;32(1):129-39. doi: 10.1016/j.cct.2010.10.002. Epub 2010 Oct 16.
- Background: PubMed 33572483Chen B, Shin S. Bibliometric Analysis on Research Trend of Accidental Falls in Older Adults by Using Citespace-Focused on Web of Science Core Collection (2010-2020). Int J Environ Res Public Health. 2021 Feb 9;18(4):1663. doi: 10.3390/ijerph18041663.
- Background: PubMed 32671316Ortega FB, Cadenas-Sanchez C, Lee DC, Ruiz JR, Blair SN, Sui X. Fitness and Fatness as Health Markers through the Lifespan: An Overview of Current Knowledge. Prog Prev Med (N Y). 2018 Apr 2;3(2):e0013. doi: 10.1097/pp9.0000000000000013. eCollection 2018 Apr.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danish Hassan principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly Care and Functional Fitness, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Senior Fitness Test (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05098496, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.