Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility

Obesity Clinical Trial

— RISE  

Official title:

Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806336
• Other study ID #: E1813-R
• Secondary ID: 1I01RX001813-01A
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 3, 2016
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 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.

Description:

Note: new recruitment on hold due to COVID-19

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age >= 60

• 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

Exclusion Criteria:

• 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

• NYHA Class 3 or 4 heart failure

• Symptomatic angina at rest or during exercise

• Syncope within the past 12 months without known cause or resolution

• 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 Gerofit or MOVE

• Poorly controlled diabetes as defined by HbA1C >10% or frequent hypoglycemic episodes

• Currently undergoing chemotherapy and/or radiation therapy for cancer treatment

Related Conditions & MeSH terms

• Dysmobility
• Obesity
• Weight Loss

Intervention

Behavioral:
• Multi Modal Balance Training
Group balance class, obstacle course, strengthening exercises
• Weight Loss
Nutritional counseling to achieve 500 kcal standard hypocaloric diet

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6 minute walk distance	Distance walked during the 6 minute walking test	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	Change in VO2peak	VO2peak measured during graded exercise treadmill test to volitional fatigue	baseline, 6 months, 12 months, 24 months
Secondary	Change in 6 minute walk with VO2 measurement	6 minute walk with submaximal assessment of oxygen uptake.	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	Change in Muscle mass/body composition as assessed by DXA scan	DXA scan	baseline, 6 months, 12 months, 24 months
Secondary	Change in Quality of Life, LLDFI	LLDFI Questionnaires	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	Change in gait biomechanics	Gait biomechanics as assessed by walking mechanics on the GAITmat	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	Change in short physical performance battery	Component scores of the standing balance battery, usual gait speed, and repeated chair stands (which make up the short physical performance battery test); as well as overall short physical performance battery score	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	Change in four square step test	Dynamic test of balance involving change in stepping direction.	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	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.	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	Change in Muscle mass/body composition as assessed by CT scan	CT scan	baseline, 6 months, 12 months, 24 months
Secondary	Change in ADL/IADL questionnaire	Self-reported ability to complete activities of daily living and independent activities of daily living.	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	Change in CHAMPS questionnaire	Self-reported physical activities questionnaire.	baseline, 3 months, 6 months, 12 months, 24 months
Secondary	Change in MoCA	Questionnaire assessing global cognitive function	baseline, 3 months, 6 months, 12 months, 24 months