ObesityINFINITENCT01048736
Investigating Fitness Interventions in the Elderly (INFINITE)
A study testing Exercise Only and Exercise + Diet in people with Obesity and Older Adults, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Aging is associated with declines in aerobic capacity, exercise tolerance, and functional endurance that lead to physical disability and loss of independence. Furthermore, the existing high prevalence of obesity in the elderly is greatly exacerbating these aging-related declines in function. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Older Adults, Sedentary
- What is being tested?
- Exercise Only and Exercise + Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2014
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- BMI=30-34.9 kg/m2
- Sedentary for past 6 months (<30 min, 3 d/wk of exercise, including walking)
- Normal cognitive function (MMSE >24)
- No contraindications for participation in weight loss or exercise (e.g., severe arthritis or musculoskeletal disorders)
- Able to provide own transportation to study visits and intervention
- No drug abuse or excessive alcohol use (> 7 drinks/week)
- Not dependent on a cane or walker
Who cannot join
- Weight loss or gain (±5%) in past 6 months
- Body weight >136.4 kg (DXA limit is 300 lbs)
- Smoker (No nicotine within past year)
- Osteoporosis (T-score ≥ -2.5)
- Abnormal kidney function tests
- Insulin-dependent or uncontrolled diabetes
Show all 13Show fewer
- Uncontrolled hypertension (BP>200/110 mmHg)
- Hypertriglyceridemia (TG>400 mg/dl)
- Past or current ischemic heart disease, angina, heart failure, peripheral artery disease, stroke, chronic respiratory disease, uncontrolled endocrine/metabolic disease, neurological or hematological disease, clinically evident edema
- Cancer requiring treatment in past 2 years, except non-melanoma skin cancers
- Severe anemia (Hb<10 g/100 ml)
- Hip fracture, hip or knee replacement, or spinal surgery in past 6 months
- Regular use of medications that influence study variables (growth/steroid hormones, estrogen, anti-inflammatory, beta blockers, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina
About this study
Aging is associated with declines in aerobic capacity, exercise tolerance, and functional endurance that lead to physical disability and loss of independence. Furthermore, the existing high prevalence of obesity in the elderly is greatly exacerbating these aging-related declines in function. To date, regular exercise is the only known therapy to consistently improve aerobic function, and perhaps delay the onset of disability. Although aerobic exercise training does benefit both aerobic capacity and endurance even in obese persons, some data show that the maximal efficacy of exercise for improving aerobic function is blunted by obesity. In addition, our preliminary data show a potential dose-response benefit of concomitant fat loss on exercise-induced improvements in aerobic function. Thus, combining an exercise intervention with caloric restriction resulting in fat loss may be more efficacious for improving aerobic function than exercise alone in obese elderly, a population at high risk for disability. The purpose of this study is to determine whether the amount of fat loss (achieved through controlled underfeeding) affects the magnitude of improvement in aerobic function (maximal aerobic capacity and endurance) in response to a standardized exercise training stimulus that follows current recommendations for older persons.
Read the detailed description
Design Overview:
Phase 1 involves recruitment and screening followed by baseline research testing (Phase 2). Next, subjects will be randomly assigned to one of three 5-month treatments (Phase 3): exercise and high-caloric restriction diet, exercise and low-caloric restriction diet, or exercise only. Subjects will complete follow-up testing after their 5 month intervention.
Interventions:
Dietary interventions: All participants will be randomly assigned to an exercise intervention with either no dietary intervention (EX Only), or 1 of 2 hypocaloric controlled diets: 1) -250 kcal/day deficit for low fat loss (EX+LOW CR) or 2) -600 kcal/day deficit for high fat loss (EX+HIGH CR) for 20 weeks.
All meals are prepared individually after participants choose from a hypocaloric menu designed by the RD to provide a balanced, healthy diet. The calorie level assigned for each person will provide him/her with an absolute daily caloric deficit consistent with their group assignment (-600 or -250 kcals/day). Individual calorie levels will be prescribed to provide calorie levels to the nearest 50 kcals (e.g., 1100 kcal, 1150 kcal, 1200 kcal, etc.). They are educated by the GCRC RDs and provided menus to guide their food purchasing and preparation of daily breakfast meals that are consistent with the prescribed calorie level. They are asked to consume only the food that is given to them or that is approved from the breakfast menu. All participants will pick up their food 3 times/wk during the intervention, and are asked to keep a log of everything they eat or drink.
Exercise intervention: The exercise will take place in an exercise facility at the Geriatric Research Center on the campus of the Wake Forest University/Baptist Medical Center. Two study personnel, including at least one trained technician, will supervise all exercise sessions. Emergency equipment will be kept on site during exercise sessions. Blood pressure and heart rate (HR) will be measured before each exercise session and subjects will warm-up by walking for 3-5 min at a slow pace and will then walk at an intensity of 65-70% of heart rate reserve (HRR, assessed during the VO2max test). The duration of walking exercise will progress from 15-20 mins at 50% HRR the 1st week to 30 mins at 65-70% HRR by the end of the 6th week and thereafter. Each walking session will end with a 3-5 min cool-down followed by 5 min of large muscle flexibility exercise.
- Conditions
- Obesity, Older Adults, Sedentary
- Being tested
- Exercise Only, Exercise + Diet
- Keywords
- obesity, exercise, intensity, weight loss, diet
- Medical subject headings
- Obesity, Sedentary Behavior, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise OnlyBehavioural
Also called EX
4 d/wk of aerobic exercise
Exercise + DietBehavioural
Also called EX+Low CR
Exercise 4d/wk with moderate caloric restriction (-250 kcal/d deficit) designed for low fat loss (EX+Low CR; ~4.5 kg weight loss).
Exercise + DietBehavioural
Also called EX+ High CR
Exercise 4d/wk with intensive caloric restriction (-600 kcal/d deficit) designed for high fat loss (EX+High CR; ~10.9 kg weight loss)
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | All treatment groups will receive 4d/wk of exercise Receives: Behavioral: Exercise Only |
| Exercise + Diet (-250 kcal/d deficit) | Experimental | Exercise 4d/wk with moderate caloric restriction (-250 kcal/d deficit) designed for low fat loss (EX+Low CR; ~4.5 kg weight loss), Receives: Behavioral: Exercise + Diet |
| Exercise + Diet (-600 kcal/d deficit) | Experimental | Exercise 4d/wk with intensive caloric restriction (-600 kcal/d deficit) designed for high fat loss (EX+High CR; ~10.9 kg weight loss) Receives: Behavioral: Exercise + Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal aerobic capacity (VO2max) and functional endurance (400 m walk time)
Measured: assessment visits will take place at baseline and post 5 months intervention
Secondary outcomes (1)
changes in specific CVD risk factors (inflammatory markers, blood lipids, blood pressure, and glucose tolerance)
Measured: baseline and 5-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2014
- Study completionSep 2014
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 ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048736
- Sponsor's protocol ID
- IRB00008292
- Other IDs
- 40010566
- Acronym
- INFINITE
- Status last verified
- Jul 2018
- First submitted
- 11 Jan 2010
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brinkley TE, Leng I, Bailey MJ, Houston DK, Hugenschmidt CE, Nicklas BJ, Hundley WG. Effects of Exercise and Weight Loss on Proximal Aortic Stiffness in Older Adults With Obesity. Circulation. 2021 Aug 31;144(9):684-693. doi: 10.1161/CIRCULATIONAHA.120.051943. Epub 2021 Aug 2.
PubMed 34333991
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Fitness Interventions in the Elderly (INFINITE)
- ClinicalTrials.gov ID
- NCT01048736
- Acronym / sponsor ID
- INFINITE / IRB00008292
- Conditions
- Obesity, Older Adults, Sedentary
- Keywords
- obesity, exercise, intensity, weight loss, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Jan 2010 (estimated)
- 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.
Aging is associated with declines in aerobic capacity, exercise tolerance, and functional endurance that lead to physical disability and loss of independence. Furthermore, the existing high prevalence of obesity in the elderly is greatly exacerbating these aging-related declines in function. To date, regular exercise is the only known therapy to consistently improve aerobic function, and perhaps delay the onset of disability. Although aerobic exercise training does benefit both aerobic capacity and endurance even in obese persons, some data show that the maximal efficacy of exercise for improving aerobic function is blunted by obesity. In addition, our preliminary data show a potential dose-response benefit of concomitant fat loss on exercise-induced improvements in aerobic function. Thus, combining an exercise intervention with caloric restriction resulting in fat loss may be more efficacious for improving aerobic function than exercise alone in obese elderly, a population at high risk for disability. The purpose of this study is to determine whether the amount of fat loss (achieved through controlled underfeeding) affects the magnitude of improvement in aerobic function (maximal aerobic capacity and endurance) in response to a standardized exercise training stimulus that follows current recommendations for older persons.
Detailed description
Design Overview:
Phase 1 involves recruitment and screening followed by baseline research testing (Phase 2). Next, subjects will be randomly assigned to one of three 5-month treatments (Phase 3): exercise and high-caloric restriction diet, exercise and low-caloric restriction diet, or exercise only. Subjects will complete follow-up testing after their 5 month intervention.
Interventions:
Dietary interventions: All participants will be randomly assigned to an exercise intervention with either no dietary intervention (EX Only), or 1 of 2 hypocaloric controlled diets: 1) -250 kcal/day deficit for low fat loss (EX+LOW CR) or 2) -600 kcal/day deficit for high fat loss (EX+HIGH CR) for 20 weeks.
All meals are prepared individually after participants choose from a hypocaloric menu designed by the RD to provide a balanced, healthy diet. The calorie level assigned for each person will provide him/her with an absolute daily caloric deficit consistent with their group assignment (-600 or -250 kcals/day). Individual calorie levels will be prescribed to provide calorie levels to the nearest 50 kcals (e.g., 1100 kcal, 1150 kcal, 1200 kcal, etc.). They are educated by the GCRC RDs and provided menus to guide their food purchasing and preparation of daily breakfast meals that are consistent with the prescribed calorie level. They are asked to consume only the food that is given to them or that is approved from the breakfast menu. All participants will pick up their food 3 times/wk during the intervention, and are asked to keep a log of everything they eat or drink.
Exercise intervention: The exercise will take place in an exercise facility at the Geriatric Research Center on the campus of the Wake Forest University/Baptist Medical Center. Two study personnel, including at least one trained technician, will supervise all exercise sessions. Emergency equipment will be kept on site during exercise sessions. Blood pressure and heart rate (HR) will be measured before each exercise session and subjects will warm-up by walking for 3-5 min at a slow pace and will then walk at an intensity of 65-70% of heart rate reserve (HRR, assessed during the VO2max test). The duration of walking exercise will progress from 15-20 mins at 50% HRR the 1st week to 30 mins at 65-70% HRR by the end of the 6th week and thereafter. Each walking session will end with a 3-5 min cool-down followed by 5 min of large muscle flexibility exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: Exercise OnlyAll treatment groups will receive 4d/wk of exercise |
| Exercise + Diet (-250 kcal/d deficit) | Experimental | Behavioral: Exercise + DietExercise 4d/wk with moderate caloric restriction (-250 kcal/d deficit) designed for low fat loss (EX+Low CR; ~4.5 kg weight loss), |
| Exercise + Diet (-600 kcal/d deficit) | Experimental | Behavioral: Exercise + DietExercise 4d/wk with intensive caloric restriction (-600 kcal/d deficit) designed for high fat loss (EX+High CR; ~10.9 kg weight loss) |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- BMI=30-34.9 kg/m2
- Sedentary for past 6 months (<30 min, 3 d/wk of exercise, including walking)
- Normal cognitive function (MMSE >24)
- No contraindications for participation in weight loss or exercise (e.g., severe arthritis or musculoskeletal disorders)
- Able to provide own transportation to study visits and intervention
Key exclusion criteria (13 listed)
- Weight loss or gain (±5%) in past 6 months
- Body weight >136.4 kg (DXA limit is 300 lbs)
- Smoker (No nicotine within past year)
- Osteoporosis (T-score ≥ -2.5)
- Abnormal kidney function tests
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 |
|---|---|---|
| Exercise OnlyAlso: EX4 d/wk of aerobic exercise | Behavioural | Exercise |
| Exercise + DietAlso: EX+Low CRExercise 4d/wk with moderate caloric restriction (-250 kcal/d deficit) designed for low fat loss (EX+Low CR; ~4.5 kg weight loss). | Behavioural | Exercise + Diet (-250 kcal/d deficit) |
| Exercise + DietAlso: EX+ High CRExercise 4d/wk with intensive caloric restriction (-600 kcal/d deficit) designed for high fat loss (EX+High CR; ~10.9 kg weight loss) | Behavioural | Exercise + Diet (-600 kcal/d deficit) |
Primary outcome
maximal aerobic capacity (VO2max) and functional endurance (400 m walk time)
Time frame: assessment visits will take place at baseline and post 5 months intervention
1 secondary outcome
changes in specific CVD risk factors (inflammatory markers, blood lipids, blood pressure, and glucose tolerance)
Time frame: baseline and 5-month follow-up
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 20 Jan 2026.
- Derived from this study: PubMed 34333991Brinkley TE, Leng I, Bailey MJ, Houston DK, Hugenschmidt CE, Nicklas BJ, Hundley WG. Effects of Exercise and Weight Loss on Proximal Aortic Stiffness in Older Adults With Obesity. Circulation. 2021 Aug 31;144(9):684-693. doi: 10.1161/CIRCULATIONAHA.120.051943. Epub 2021 Aug 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Only and Exercise + Diet in people with Obesity and Older Adults, run by Wake Forest University Health Sciences 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 7 inclusion and 13 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 20 Jan 2026. 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?
maximal aerobic capacity (VO2max) and functional endurance (400 m walk time) (time frame: assessment visits will take place at baseline and post 5 months intervention). 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 NCT01048736, 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 20 Jan 2026.