Sedentary Status of Older AdultsPASAINCT03457064
Physical Activity With Social Support Adherence Intervention
A study testing PA+Social Adherence Intervention(PASAI) in people with Sedentary Status of Older Adults, run by Professor Jiska Cohen-Mansfield.
Trial summary
The study compares two programs to increase physical activity among sedentary old persons. The first is a provision of a free physical activity program tailored to their abilities. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Status of Older Adults
- What is being tested?
- PA+Social Adherence Intervention(PASAI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2011to 1 Feb 2018
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Sedentary older adults.
- Residents in congregate housing.
Who cannot join
- Age under 70.
- Not completing an informed consent form.
About this study
Official title: Enhancing Physical Activity With a Social Support Adherence Intervention
The study compares two programs to increase physical activity among sedentary old persons. The first is a provision of a free physical activity program tailored to their abilities. The other combines the same free physical activity with an adherence intervention which focuses on social contact with others in the program and on enhancing self-efficacy.
- Conditions
- Sedentary Status of Older Adults
- Being tested
- PA+Social Adherence Intervention(PASAI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA+Social Adherence Intervention(PASAI)Behavioural
Also called Physical Activity (PA)
While both physical activity programs were tailored to match participants' physical needs and abilities, the PA+Social Adherence Intervention(PASAI) introduced elements to promote and strengthen self-efficacy and social interaction among participants.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity (PA) | No intervention | Physical activity (PA) involved a program of physical exercise alone. |
| PA+Social Adherence Intervention(PASAI) | Active comparator | PA+Social Adherence Intervention(PASAI) involved a program of physical exercise combined with a social adherence intervention. Receives: Behavioral: PA+Social Adherence Intervention(PASAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in the Rapid Assessment of Physical Activity (RAPA).
RAPA is an easily administered nine item questionnaire developed to assess physical activity levels among older adults.
Measured: Baseline and Three Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Nov 2011
- Primary completion1 Jul 2012
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary Status of Older AdultsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Jiska Cohen-Mansfield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Jiska Cohen-Mansfield, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457064
- Sponsor's protocol ID
- TelAvivUniv
- Acronym
- PASAI
- Status last verified
- Mar 2018
- First submitted
- 20 Feb 2018
- Last updated
- 8 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen-Mansfield J, Sommerstein M. Motivating Inactive Seniors to Participate in Physical Activity: A Pilot RCT. Am J Health Behav. 2019 Jan 1;43(1):195-206. doi: 10.5993/AJHB.43.1.16.
PubMed 30522577
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Physical Activity With a Social Support Adherence Intervention
- ClinicalTrials.gov ID
- NCT03457064
- Acronym / sponsor ID
- PASAI / TelAvivUniv
- Conditions
- Sedentary Status of Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Professor Jiska Cohen-MansfieldUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 1 Jul 2012 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 7 Mar 2018 (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.
The study compares two programs to increase physical activity among sedentary old persons. The first is a provision of a free physical activity program tailored to their abilities. The other combines the same free physical activity with an adherence intervention which focuses on social contact with others in the program and on enhancing self-efficacy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity (PA) | No intervention | –Physical activity (PA) involved a program of physical exercise alone. |
| PA+Social Adherence Intervention(PASAI) | Active comparator | Behavioral: PA+Social Adherence Intervention(PASAI)PA+Social Adherence Intervention(PASAI) involved a program of physical exercise combined with a social adherence intervention. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Sedentary older adults.
- Residents in congregate housing.
Key exclusion criteria (2 listed)
- Age under 70.
- Not completing an informed consent form.
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 |
|---|---|---|
| PA+Social Adherence Intervention(PASAI)Also: Physical Activity (PA)While both physical activity programs were tailored to match participants' physical needs and abilities, the PA+Social Adherence Intervention(PASAI) introduced elements to promote and strengthen self-efficacy and social interaction among participants. | Behavioural | PA+Social Adherence Intervention(PASAI) |
Primary outcome
The change from baseline in the Rapid Assessment of Physical Activity (RAPA).
Time frame: Baseline and Three Months.
RAPA is an easily administered nine item questionnaire developed to assess physical activity levels among older adults.
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 8 Mar 2018.
- Derived from this study: PubMed 30522577Cohen-Mansfield J, Sommerstein M. Motivating Inactive Seniors to Participate in Physical Activity: A Pilot RCT. Am J Health Behav. 2019 Jan 1;43(1):195-206. doi: 10.5993/AJHB.43.1.16.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PA+Social Adherence Intervention(PASAI) in people with Sedentary Status of Older Adults, run by Professor Jiska Cohen-Mansfield.
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 2 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 8 Mar 2018. 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?
The change from baseline in the Rapid Assessment of Physical Activity (RAPA). (time frame: Baseline and Three Months.). 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 NCT03457064, which also lists 1 linked publication.
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 8 Mar 2018.