ObesityRISENCT02806336
Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
A study testing Multi Modal Balance Training (MMBI) and Weight Loss (WL) in people with Obesity and Dysmobility, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Obesity is a major risk factor for mobility problems in older adults and many older adults use a walking aid to help with their mobility. The use of a walking aid changes normal walking patterns and makes walking harder, leading people to have more functional problems. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Obesity, Dysmobility
- What is being tested?
- Multi Modal Balance Training (MMBI) and Weight Loss (WL)
- 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
- 3 Oct 2016to 30 Jun 2022
- 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
- Age >= 60
- Body Mass Index (BMI) >= 30 kg/m2
- Dysmobility as define by 1 or more of the following: Use of or prescribed an assistive walking device, measured gait speed < 1.0 m/s, Four Square Step Test >/= 12 secs OR inability to complete the Four Square Step Test, and/or self-reported difficulty walking 1 km.
- Community dwelling
Who cannot join
- Unable to walk >0.2 mph on a treadmill for 2 minutes
- Poorly controlled hypertension >180 systolic or >100 diastolic
- Episodes of acute coronary syndrome, coronary revascularization, or major cardiac/vascular procedures within the prior 6 months
- New York Heart Association Class 3 or 4 heart failure
- Symptomatic angina at rest or during exercise
- Syncope within the past 12 months without known cause or resolution
Show all 14Show fewer
- Chronic lung disease required oxygen dependency
- Severe spinal stenosis limiting ambulation
- Known dementia
- Mini Mental State Exam score <24
- Transtibial or above the knee amputation
- Currently enrolled and active in a supervised exercise program or Weight Management Program for Veterans (MOVE)
- Poorly controlled diabetes as defined by HbA1C >10% or frequent hypoglycemic episodes
- Currently undergoing chemotherapy and/or radiation therapy for cancer treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Obesity is a major risk factor for mobility problems in older adults and many older adults use a walking aid to help with their mobility. The use of a walking aid changes normal walking patterns and makes walking harder, leading people to have more functional problems. The purpose of this study is to test the effects of 12 months of a multi-modal balance intervention (MMBI) with supervised weight loss compared to MMBI only on fitness, functional performance, balance, and economy of gait. Participants will be one of 120 participants in the VA Maryland Health Care System (VAMHCS). Participation in this study is voluntary. The research will be conducted at the VAMHCS. The entire study will take approximately 4 years to complete. Subjects' participation in the study will last 24 months.
Read the detailed description
Note: Study has been completed, enrollment and study interventions were severely impacted by coronavirus disease 2019 (COVID)
Older obese adults suffer disproportionately from walking mobility limitations. Sedentary, obese older adults are at an increased risk for having or developing difficulties with mobility. These individuals are often excluded from studies due to their advanced mobility limitations. A number of studies have compared the effects of weight loss alone, exercise alone, or weight loss in combination with exercise on functional performance in older adults, but none of the studies have specifically targeted subjects who use walking assistive devices. The purpose of this study is to test the effects of a 12 month multi-modal exercise rehabilitation intervention with a nutrition program versus a nutrition program only on fitness, functional performance, mobility, and muscle mass. The results of this study will lead to new and more effective interventions that could reduce disability, fall risk, injury-related hospitalization and death in older Veterans.
- Conditions
- Obesity, Dysmobility
- Being tested
- Multi Modal Balance Training (MMBI), Weight Loss (WL)
- Keywords
- exercise training, assistive device, weight loss, function, mobility
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi Modal Balance Training (MMBI)Behavioural
Also called MMBI
Group balance class, obstacle course, strengthening exercises
Weight Loss (WL)Behavioural
Also called WL
Nutritional counseling to achieve 500 kcal standard hypocaloric diet
| Study group | Role | What they receive |
|---|---|---|
| Multi Modal Balance Training & Weight Loss | Experimental | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Weekly nutrition sessions for individual dietary recommendations designed to produce about a 10% weight loss over the first six months of the study. Receives: Behavioral: Multi Modal Balance Training (MMBI); Behavioral: Weight Loss (WL) |
| Multi Modal Balance Training Only | Active comparator | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Receives: Behavioral: Multi Modal Balance Training (MMBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6 Minute Walk Distance
Distance walked during the 6 minute walking test
Measured: 6 months
Secondary outcomes (6)
Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement
6 minute walk with submaximal assessment of oxygen uptake as a measure of fitness.
Measured: 6 months
Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan
The DXA scan provides information about the body composition including total body fat, and lean muscle mass
Measured: baseline, 6 months
Change in Gait Biomechanics
Gait biomechanics as assessed by walking mechanics on the gait rite mat. Scale range 0 - 24 with higher scores indicating better outcome.
Measured: 6 months
Change in Short Physical Performance Battery
overall short physical performance battery score. Scale range 0 - 12 with higher scores indicating better possible function.
Measured: baseline, 3 months
Change in Four Square Step Test
Dynamic test of balance involving change in stepping direction.
Measured: baseline, 3 months
Change in 8 Foot up and go
Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility.
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start3 Oct 2016
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 ObesityStudies 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
- Model description
- Two group randomized control trial (RCT)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Leslie I Katzel, MD PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806336
- Sponsor's protocol ID
- E1813-R
- Other IDs
- 1I01RX001813-01A1
- Acronym
- RISE
- Status last verified
- Mar 2025
- First submitted
- 2 Jun 2016
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
- ClinicalTrials.gov ID
- NCT02806336
- Acronym / sponsor ID
- RISE / E1813-R
- Conditions
- Obesity, Dysmobility
- Keywords
- exercise training, assistive device, weight loss, function, mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a major risk factor for mobility problems in older adults and many older adults use a walking aid to help with their mobility. The use of a walking aid changes normal walking patterns and makes walking harder, leading people to have more functional problems. The purpose of this study is to test the effects of 12 months of a multi-modal balance intervention (MMBI) with supervised weight loss compared to MMBI only on fitness, functional performance, balance, and economy of gait. Participants will be one of 120 participants in the VA Maryland Health Care System (VAMHCS). Participation in this study is voluntary. The research will be conducted at the VAMHCS. The entire study will take approximately 4 years to complete. Subjects' participation in the study will last 24 months.
Detailed description
Note: Study has been completed, enrollment and study interventions were severely impacted by coronavirus disease 2019 (COVID)
Older obese adults suffer disproportionately from walking mobility limitations. Sedentary, obese older adults are at an increased risk for having or developing difficulties with mobility. These individuals are often excluded from studies due to their advanced mobility limitations. A number of studies have compared the effects of weight loss alone, exercise alone, or weight loss in combination with exercise on functional performance in older adults, but none of the studies have specifically targeted subjects who use walking assistive devices. The purpose of this study is to test the effects of a 12 month multi-modal exercise rehabilitation intervention with a nutrition program versus a nutrition program only on fitness, functional performance, mobility, and muscle mass. The results of this study will lead to new and more effective interventions that could reduce disability, fall risk, injury-related hospitalization and death in older Veterans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two group randomized control trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Multi Modal Balance Training & Weight Loss | Experimental | Behavioral: Multi Modal Balance Training (MMBI), Behavioral: Weight Loss (WL)Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Weekly nutrition sessions for individual dietary recommendations designed to produce about a 10% weight loss over the first six months of the study. |
| Multi Modal Balance Training Only | Active comparator | Behavioral: Multi Modal Balance Training (MMBI)Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 60
- Body Mass Index (BMI) >= 30 kg/m2
- Dysmobility as define by 1 or more of the following: Use of or prescribed an assistive walking device, measured gait speed < 1.0 m/s, Four Square Step Test >/= 12 secs OR inability to complete the Four Square Step Test, and/or self-reported difficulty walking 1 km.
- Community dwelling
Key exclusion criteria (14 listed)
- Unable to walk >0.2 mph on a treadmill for 2 minutes
- Poorly controlled hypertension >180 systolic or >100 diastolic
- Episodes of acute coronary syndrome, coronary revascularization, or major cardiac/vascular procedures within the prior 6 months
- New York Heart Association Class 3 or 4 heart failure
- Symptomatic angina at rest or during exercise
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 |
|---|---|---|
| Multi Modal Balance Training (MMBI)Also: MMBIGroup balance class, obstacle course, strengthening exercises | Behavioural | Multi Modal Balance Training & Weight Loss, Multi Modal Balance Training Only |
| Weight Loss (WL)Also: WLNutritional counseling to achieve 500 kcal standard hypocaloric diet | Behavioural | Multi Modal Balance Training & Weight Loss |
Primary outcome
Change in 6 Minute Walk Distance
Time frame: 6 months
Distance walked during the 6 minute walking test
6 secondary outcomes
Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement
Time frame: 6 months
Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan
Time frame: baseline, 6 months
Change in Gait Biomechanics
Time frame: 6 months
Change in Short Physical Performance Battery
Time frame: baseline, 3 months
Change in Four Square Step Test
Time frame: baseline, 3 months
Change in 8 Foot up and go
Time frame: baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- 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.
Leslie I Katzel, MD PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi Modal Balance Training (MMBI) and Weight Loss (WL) in people with Obesity and Dysmobility, 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 4 inclusion and 14 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 9 Apr 2025. 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 9 Apr 2025). 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?
Change in 6 Minute Walk Distance (time frame: 6 months). 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 9 Apr 2025.