Diabetes Mellitus Type 2NCT01308008
Home Exercise to Enhance Mobility for Older Diabetics
A study testing home exercise/physical activity (PA) enhancement program with behavioral support and flex and toning health education program in people with Diabetes Mellitus Type 2, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- home exercise/physical activity (PA) enhancement program with behavioral support and flex and toning health education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary
- Type 2 Diabetes
- No medical contraindications to exercise
Who cannot join
- Enrolled in intensive exercise program
- Unable to cooperate with protocol (e.g. cognitive impairment)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
Official title: Home Program to Enhance Mobility in Older Veteran Diabetics
The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year. This research can lead to an exercise/PA enhancement program that can coordinate with VA outreach programs, targeting older Veterans who are not in the immediate vicinity of a major VA site. Ultimately, this should create a model to which physicians and other providers could refer comorbid diabetes patients.
Read the detailed description
The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. To facilitate adherence to a long-term program, the investigators plan an individualized, home exercise/physical activity (PA) enhancement program with behavioral support. The rationale for this program is based on: 1) the feasibility of a previously funded VA RR\&D controlled trial (led by the present research team) in sedentary older adults with diabetes that improved mobility performance, specifically usual gait speed; 2) the need for longer term and functionally-relevant interventions (specifically mobility-oriented) for older adult diabetics; 3) the potential to use telephonic nurse support to assist in overcoming barriers to exercise and in dealing with intercurrent illness, factors that are key in this comorbid patient group; and 4) the potential to increase the focus on objectively measured physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- home exercise/physical activity (PA) enhancement program with behavioral support, flex and toning health education program
- Keywords
- Type 2 Diabetes Mellitus, Mobility Limitation
- Medical subject headings
- Diabetes Mellitus, Type 2, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home exercise/physical activity (PA) enhancement program with behavioral supportBehavioural
Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
flex and toning health education programBehavioural
Initial flex and toning program continued on follow-up along with health education
| Study group | Role | What they receive |
|---|---|---|
| Functional exercise- home physical activity | Experimental | On-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with telephonic behavioral support Receives: Behavioral: home exercise/physical activity (PA) enhancement program with behavioral support |
| Flex and tone- home health education | Active comparator | Initial on-site flex and toning program continued on follow-up along with health education Receives: Behavioral: flex and toning health education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfortable Gait Speed
Gait velocity over 6 meters
Measured: 1 year
Six Minute Walk Distance
Walk distance covered in feet over 6 minutes
Measured: one year
Secondary outcomes (1)
Physical Activity
Average physical activity counts per waking minute
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Neil Alexander, MD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308008
- Sponsor's protocol ID
- E7547-R
- Status last verified
- Nov 2018
- First submitted
- 1 Mar 2011
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Program to Enhance Mobility in Older Veteran Diabetics
- ClinicalTrials.gov ID
- NCT01308008
- Acronym / sponsor ID
- E7547-R
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Type 2 Diabetes Mellitus, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Nov 2011
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 3 Mar 2011 (estimated)
- Results
- Posted 8 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year. This research can lead to an exercise/PA enhancement program that can coordinate with VA outreach programs, targeting older Veterans who are not in the immediate vicinity of a major VA site. Ultimately, this should create a model to which physicians and other providers could refer comorbid diabetes patients.
Detailed description
The goal of the proposed research is to test whether a long-term exercise program in sedentary Veterans with diabetes will produce sustained improvement in mobility performance and physical activity. To facilitate adherence to a long-term program, the investigators plan an individualized, home exercise/physical activity (PA) enhancement program with behavioral support. The rationale for this program is based on: 1) the feasibility of a previously funded VA RR\&D controlled trial (led by the present research team) in sedentary older adults with diabetes that improved mobility performance, specifically usual gait speed; 2) the need for longer term and functionally-relevant interventions (specifically mobility-oriented) for older adult diabetics; 3) the potential to use telephonic nurse support to assist in overcoming barriers to exercise and in dealing with intercurrent illness, factors that are key in this comorbid patient group; and 4) the potential to increase the focus on objectively measured physical activity. In this proposed research, 240 sedentary older adult diabetics (aged 60 and over) will be randomly allocated into a customized, primarily home-based, functionally-oriented exercise program with nurse support intervention (I) group versus a flexibility and toning, health education control (C) group, and test outcomes in functional mobility and physical activity at 4 weeks, 6 months and one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional exercise- home physical activity | Experimental | Behavioral: home exercise/physical activity (PA) enhancement program with behavioral supportOn-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with telephonic behavioral support |
| Flex and tone- home health education | Active comparator | Behavioral: flex and toning health education programInitial on-site flex and toning program continued on follow-up along with health education |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sedentary
- Type 2 Diabetes
- No medical contraindications to exercise
Key exclusion criteria (2 listed)
- Enrolled in intensive exercise program
- Unable to cooperate with protocol (e.g. cognitive impairment)
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 |
|---|---|---|
| home exercise/physical activity (PA) enhancement program with behavioral supportInitial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support | Behavioural | Functional exercise- home physical activity |
| flex and toning health education programInitial flex and toning program continued on follow-up along with health education | Behavioural | Flex and tone- home health education |
Primary outcome
Comfortable Gait Speed
Time frame: 1 year
Gait velocity over 6 meters
Six Minute Walk Distance
Time frame: one year
Walk distance covered in feet over 6 minutes
1 secondary outcome
Physical Activity
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Neil Alexander, MD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home exercise/physical activity (PA) enhancement program with behavioral support and flex and toning health education program in people with Diabetes Mellitus Type 2, run by VA Office of Research and Development 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 3 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 Nov 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?
Yes. Results are posted in the registry (first posted 8 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comfortable Gait Speed (time frame: 1 year). The study lists 2 primary outcomes in all. 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 8 Nov 2018.