Mobility LimitationNCT03514160
Relationships Between Exercise and Emotion Regulation on Physical Activity in Frail Older Adults
A study testing Group exercise in people with Mobility Limitation and Sedentary Lifestyle, run by Northeastern University at 1 site in United States.
Trial summary
Frailty in older adults is a consequence of physical inactivity, which leads to poor physical function, disability and poor health outcomes. Nearly 60% of older adults report inactivity. Emotion regulation strategies have affective, cognitive and social consequences. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Mobility Limitation, Sedentary Lifestyle, Older Adults
- What is being tested?
- Group exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jan 2016
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling older adults 60+ years of age
- Men and women
- Frail older adults with impaired mobility (gait speed < 0.8 m/sec)
- Sedentary older adults
Who cannot join
- Unable to give consent
- Unable to exercise
- Unable to travel to the community site
- Unstable chronic conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeastern University
Boston, Massachusetts, 02115
About this study
Official title: Does Exercise-induced Improvements in Emotion Regulation Enhance Daily Physical Activity and Well-being in Frail Sedentary Older Adults?
Frailty in older adults is a consequence of physical inactivity, which leads to poor physical function, disability and poor health outcomes. Nearly 60% of older adults report inactivity. Emotion regulation strategies have affective, cognitive and social consequences. Positive emotions are significantly associated with a higher ability to perform activities of daily living. There is a gap in the understanding of how exercise influences the selection of emotion regulation strategies (avoidant vs. adaptive) in frail older adults. The investigators propose to examine the interactions between regular exercise, selection of emotional regulation strategies, and daily physical activity in frail sedentary older adults.
Read the detailed description
- Determine the choice of emotion regulation strategies used by frail sedentary older adults (60+ years; n=24). Frailty will be defined as a gait speed <0.8 m/sec. Hypothesis: Frail sedentary older adults will choose avoidant emotion regulation strategies.
- Examine whether a peer-led, community-based, group-exercise program lasting 12-weeks improves the selection of emotion regulation strategies in frail sedentary older adults as compared to those receiving support services (12/group). Hypothesis: Exercise will result in higher use of adaptive emotion regulation strategies than support services.
- Examine if improved selection of emotional regulation strategies with exercise translates into increased daily physical activity and reduced sedentary behavior by frail older adults as compared to those receiving support services. Hypothesis: Exercise will significantly increase daily physical activity and decrease sedentary behavior than support services.
- Determine if improvements in emotional regulation strategy selection and daily physical activity levels positively influence health and well-being (i.e. health status, physical function, mood, depressive symptoms, anxiety, and sense of loneliness and isolation).
Hypothesis: Exercise-induced improvements in emotion regulation and increased daily physical activity will be associated with improved overall health and well-being as compared to support services.
- Conditions
- Mobility Limitation, Sedentary Lifestyle, Older Adults
- Being tested
- Group exercise
- Medical subject headings
- Mobility Limitation, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group exerciseBehavioural
Group exercise based on the American College of Sports Medicine guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Group exercise | Active comparator | Group exercise training at a community site. Exercises included supervised upper and lower-body strength and balance exercises twice per week. Hand-made, weighted bars were used for resistance props and balance. The exercises included: chair squats; standing single leg hip abduction; hip extension; balance heal-to-toe walking; seated hip adduction and knee extension; wall push-ups; bent-over rows; shoulder press; elbow flexion and extension). Receives: Behavioral: Group exercise |
| Attention-Control group | No intervention | Attendance to community site usual activities offered to older adults. Participants in this group were offered the exercise routine after completing the 12-week study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seven-day free living physical activity
Number of steps per day were objectively measured with an activity monitor worn for a seven-day period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study startApr 2015
- Primary completionAug 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies 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
- Model description
- Randomization to group exercise or an attention-control group for 12 weeks (2:1 ratio). Group exercise sessions took place once per week at a community center.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Castaneda-Sceppa, MD, PhD, Principal investigator, Professor and Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514160
- Sponsor's protocol ID
- G00004606
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Exercise-induced Improvements in Emotion Regulation Enhance Daily Physical Activity and Well-being in Frail Sedentary Older Adults?
- ClinicalTrials.gov ID
- NCT03514160
- Acronym / sponsor ID
- G00004606
- Conditions
- Mobility Limitation, Sedentary Lifestyle, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 May 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.
Frailty in older adults is a consequence of physical inactivity, which leads to poor physical function, disability and poor health outcomes. Nearly 60% of older adults report inactivity. Emotion regulation strategies have affective, cognitive and social consequences. Positive emotions are significantly associated with a higher ability to perform activities of daily living. There is a gap in the understanding of how exercise influences the selection of emotion regulation strategies (avoidant vs. adaptive) in frail older adults. The investigators propose to examine the interactions between regular exercise, selection of emotional regulation strategies, and daily physical activity in frail sedentary older adults.
Detailed description
- Determine the choice of emotion regulation strategies used by frail sedentary older adults (60+ years; n=24). Frailty will be defined as a gait speed <0.8 m/sec. Hypothesis: Frail sedentary older adults will choose avoidant emotion regulation strategies.
- Examine whether a peer-led, community-based, group-exercise program lasting 12-weeks improves the selection of emotion regulation strategies in frail sedentary older adults as compared to those receiving support services (12/group). Hypothesis: Exercise will result in higher use of adaptive emotion regulation strategies than support services.
- Examine if improved selection of emotional regulation strategies with exercise translates into increased daily physical activity and reduced sedentary behavior by frail older adults as compared to those receiving support services. Hypothesis: Exercise will significantly increase daily physical activity and decrease sedentary behavior than support services.
- Determine if improvements in emotional regulation strategy selection and daily physical activity levels positively influence health and well-being (i.e. health status, physical function, mood, depressive symptoms, anxiety, and sense of loneliness and isolation).
Hypothesis: Exercise-induced improvements in emotion regulation and increased daily physical activity will be associated with improved overall health and well-being as compared to support services.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to group exercise or an attention-control group for 12 weeks (2:1 ratio). Group exercise sessions took place once per week at a community center.
| Arm | Type | Receives |
|---|---|---|
| Group exercise | Active comparator | Behavioral: Group exerciseGroup exercise training at a community site. Exercises included supervised upper and lower-body strength and balance exercises twice per week. Hand-made, weighted bars were used for resistance props and balance. The exercises included: chair squats; standing single leg hip abduction; hip extension; balance heal-to-toe walking; seated hip adduction and knee extension; wall push-ups; bent-over rows; shoulder press; elbow flexion and extension). |
| Attention-Control group | No intervention | –Attendance to community site usual activities offered to older adults. Participants in this group were offered the exercise routine after completing the 12-week study. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Community-dwelling older adults 60+ years of age
- Men and women
- Frail older adults with impaired mobility (gait speed < 0.8 m/sec)
- Sedentary older adults
Key exclusion criteria (4 listed)
- Unable to give consent
- Unable to exercise
- Unable to travel to the community site
- Unstable chronic conditions
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 |
|---|---|---|
| Group exerciseGroup exercise based on the American College of Sports Medicine guidelines. | Behavioural | Group exercise |
Primary outcome
Seven-day free living physical activity
Time frame: 12 weeks
Number of steps per day were objectively measured with an activity monitor worn for a seven-day period
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 2 May 2018.
- 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.
Carmen Castaneda-Sceppa, MD, PhD principal investigator
Professor and Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group exercise in people with Mobility Limitation and Sedentary Lifestyle, run by Northeastern University at 1 site in United States.
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 4 inclusion and 4 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 2 May 2018. 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 United States. 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?
Seven-day free living physical activity (time frame: 12 weeks). 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 2 May 2018.