AgedNCT03123757
Assessing the Determinants of 6-minute Walk Test and Its Correlation With Quality of Life
A study testing 6 Minute Walk Test, EQ-5D Survey and Short Physical Performance Battery in people with Aged, run by Precision Health Economics.
Trial summary
This study evaluates the determinants of mobility, measured by the 6-minute walk test, and its correlation with quality of life in near elderly patients. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- 6 Minute Walk Test, EQ-5D Survey and Short Physical Performance Battery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 31 Aug 2015
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to provide informed consent
- Willing to perform the 6-minute walk without the use of a walker, or the assistance of another person.
- Ability to speak and understand English
Who cannot join
- Medical condition that precludes safe participation in the 6 minute walk test
About this study
Official title: Assessing the Determinants of 6-minute Walk Test and Its Correlation With Quality of Life: A Survey of Older Adults
This study evaluates the determinants of mobility, measured by the 6-minute walk test, and its correlation with quality of life in near elderly patients.
Read the detailed description
To evaluate the determinants of mobility an its correlation with quality of life, we conducted a study that evaluated patients ability to perform the 6-minute walk test and their corresponding quality of life measured by the EQ-5D. Cognition was evaluated used the Callahan six-item screener, and additional measures of physical performance were assessed using the Short Physical Performance Battery. Participants disclosed self reported physical function and physical activity. Additionally, other participant characteristics including vital signs, medication history and healthcare utilization were determined as well as social, economic and health related information was collected.
- Conditions
- Aged
- Being tested
- 6 Minute Walk Test, EQ-5D Survey, Short Physical Performance Battery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 Minute Walk TestOther
The 6 minute walk test measures the distance walked in 6 minutes without sitting and without the use of a walker or the help of another person (a cane may be used). The walk was conducted in a wide hallway, specifically designed for this type of assessment, with a defined 20-meter course. The subject walked back and forth in the hallway for six minutes and the distance covered was recorded.
EQ-5D SurveyOther
The EQ-5D is a self-reported questionnaire that describes a respondent's health using a descriptive system comprised of five items, each representing a different health dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, respondents state whether they have no problems, slight problems, moderate problems, severe problems, or are unable to perform the activity.
Short Physical Performance BatteryOther
Also called SPPB
The SPPB is a brief performance battery based on timed short distance walk, repeated chair stands and balance test administered by trained examiners. The measurement goal for this battery is to assess lower extremity functional limitations, which indicate functional abilities and are a strong measure of risk for future disability.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Patients performed the 6-minute walk test and completed the EQ-5D quality of life questionnaire. Receives: Other: 6 Minute Walk Test; Other: EQ-5D Survey; Other: Short Physical Performance Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Quality of Life
Measured using the EQ-5D instrument
Measured: On the day of assessment
Secondary outcomes (1)
Mobility
Measured using the 6-minute walk test
Measured: On the day of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Apr 2015
- Primary completion31 Aug 2015
- Study completion31 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects enrolled in our trial performed the 6-minute walk test and completed an EQ-5D quality of life questionnaire.
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precision Health Economics
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Jason Shafrin, Precision Health Economics
- Investigators
- Jason Shafrin, PhD, Principal investigator, Precision Health Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123757
- Sponsor's protocol ID
- Mobility and Quality of Life
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Determinants of 6-minute Walk Test and Its Correlation With Quality of Life: A Survey of Older Adults
- ClinicalTrials.gov ID
- NCT03123757
- Acronym / sponsor ID
- Mobility and Quality of Life
- Conditions
- Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Precision Health EconomicsUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 21 Apr 2017 (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.
This study evaluates the determinants of mobility, measured by the 6-minute walk test, and its correlation with quality of life in near elderly patients.
Detailed description
To evaluate the determinants of mobility an its correlation with quality of life, we conducted a study that evaluated patients ability to perform the 6-minute walk test and their corresponding quality of life measured by the EQ-5D. Cognition was evaluated used the Callahan six-item screener, and additional measures of physical performance were assessed using the Short Physical Performance Battery. Participants disclosed self reported physical function and physical activity. Additionally, other participant characteristics including vital signs, medication history and healthcare utilization were determined as well as social, economic and health related information was collected.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects enrolled in our trial performed the 6-minute walk test and completed an EQ-5D quality of life questionnaire.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: 6 Minute Walk Test, Other: EQ-5D Survey, Other: Short Physical Performance BatteryPatients performed the 6-minute walk test and completed the EQ-5D quality of life questionnaire. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to provide informed consent
- Willing to perform the 6-minute walk without the use of a walker, or the assistance of another person.
- Ability to speak and understand English
Key exclusion criteria (1 listed)
- Medical condition that precludes safe participation in the 6 minute walk test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 Minute Walk TestThe 6 minute walk test measures the distance walked in 6 minutes without sitting and without the use of a walker or the help of another person (a cane may be used). The walk was conducted in a wide hallway, specifically designed for this type of assessment, with a defined 20-meter course. The subject walked back and forth in the hallway for six minutes and the distance covered was recorded. | Other | Intervention |
| EQ-5D SurveyThe EQ-5D is a self-reported questionnaire that describes a respondent's health using a descriptive system comprised of five items, each representing a different health dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, respondents state whether they have no problems, slight problems, moderate problems, severe problems, or are unable to perform the activity. | Other | Intervention |
| Short Physical Performance BatteryAlso: SPPBThe SPPB is a brief performance battery based on timed short distance walk, repeated chair stands and balance test administered by trained examiners. The measurement goal for this battery is to assess lower extremity functional limitations, which indicate functional abilities and are a strong measure of risk for future disability. | Other | Intervention |
Primary outcome
Patient-Reported Quality of Life
Time frame: On the day of assessment
Measured using the EQ-5D instrument
1 secondary outcome
Mobility
Time frame: On the day of assessment
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 21 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jason Shafrin, PhD principal investigator
Precision Health Economics
Questions about this trial
What is this clinical trial studying?
A study testing 6 Minute Walk Test, EQ-5D Survey and Short Physical Performance Battery in people with Aged, run by Precision Health Economics.
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 3 inclusion and 1 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Patient-Reported Quality of Life (time frame: On the day of assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2017.