AzTrials
AzTrials

AgingPhase 1PACENCT02203656

Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults

A Phase 1 study testing Nutritional Supplement, In-home exercise and Testosterone in people with Aging, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Aging
What is being tested?
Nutritional Supplement, In-home exercise and Testosterone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
2 sitesUnited States
Study dates
Oct 2013to Dec 2017
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Admitted to the University of Texas Medical Branch (UTMB) ACE unit with an admitting diagnosis of congestive heart failure, respiratory infection, kidney/urinary tract infection, or metabolic disorder; or other condition that will allow a subject to participate in the study after patient review
  • Aged 65 years or older
  • Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization
  • Lives within 30 miles of UTMB
  • Can stand without assistance at the time of pretesting
  • Presents no medical contraindication to wearing a loose fitting velcro strap for the accelerometer on one ankle
  • Score ≥26 on the 30-item Mini Mental State Examination or alert and oriented X3 by physician on H\&P
  • Is discharged "to home" at ACE unit discharge.

Who cannot join

  • Nursing home resident or hospice patient
  • Uncontrolled blood pressure (systolic >150, or diastolic > 100)
  • History of stroke with motor disability
  • Glomerular filtration rate (GFR) <30 mL/min/1.73m2 or evidence of kidney disease or failure
  • Liver disease ( aspartate aminotransferase (AST) /Alanine transaminase (ALT) 2 times above the normal limit, hyperbilirubinemia)
  • Recent (within 3 months) treatment with anabolic steroids
Show all 14Show fewer
  • Any other condition or event considered exclusionary by the PI and faculty physician
  • Planned or elective hospitalization within 30 days of discharge
  • Additional Exclusion Criteria for Subjects Randomized to the Testosterone Group
  • Breast or prostate cancer
  • Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml
  • PSA ≥ 3 ng/ml in men at high risk of prostate cancer, such as African Americans or men with first-degree relatives with prostate cancer
  • Hematocrit ≥ 50%
  • Decompensated heart failure as determined by a physician

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UTMB Acute Care for Elders Unit

    Galveston, Texas, 77550

  • Jennie Sealy Hospital

    Galveston, Texas, 77555

Other trials in United States

About this study

Official title: Feasibility Study of Post-hospitalization Interventions to Improve Physical Function

The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization.

Read the detailed description

The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization

Conditions
Aging
Being tested
Placebo, Nutritional Supplement, In-home exercise, Testosterone
Keywords
intervention studies, nutrition, exercise, testosterone, patient readmission
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called Control

    placebo supplement

  • Nutritional SupplementDietary supplement

    protein supplement

  • In-home exerciseBehavioural

    In-home exercise program

  • TestosteroneDrug

    Also called Testosterone enanthate

    Testosterone injection

Study groups in NCT02203656
Study groupRoleWhat they receive
Placebo SupplementPlacebo comparatorDaily placebo supplement for 30 days after discharge.
Receives: Drug: Placebo
Nutritional SupplementExperimentalDaily nutritional supplement for 30 days after discharge.
Receives: Dietary Supplement: Nutritional Supplement
In-home exercise + placeboExperimentalin-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.
Receives: Drug: Placebo; Behavioral: In-home exercise
In-home exercise + nutritionExperimentalin-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.
Receives: Dietary Supplement: Nutritional Supplement; Behavioral: In-home exercise
TestosteroneExperimentalSingle testosterone injection within 24 hours of hospital discharge.
Receives: Drug: Testosterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score

    Changes in SPPB score

    Measured: at pre-testing, 1-week post discharge and 4-week post discharge

Secondary outcomes (7)

  1. Body Composition

    Body composition will be measured using a bioimpedance scale. Changes in weight and % body fat will be calculated over the duration of the intervention.

    Measured: at pre-testing, 1-week post discharge and 4-week post discharge

  2. Hand grip strength (kg)

    Changes in hand grip will be calculated over duration of study.

    Measured: at pre-testing, 1-week post discharge and 4-week post discharge

  3. ADLS, IADLS

    Changes in Instrumental activities of daily living (IADLS), and Activities of daily living (ADLS) will be measured over the duration of the intervention.

    Measured: at pre-testing, 1-week post discharge and 4-week post discharge

  4. Physical Activity Levels

    Physical activity levels will be measured using a step activity monitor and actiwatch

    Measured: at pre-testing, 1-week post discharge and 4-week post discharge

  5. Gait Speed (m/s)

    Changes in gait speed will be calculated over duration of study.

    Measured: at pre-testing, 1-week post discharge and 4-week post discharge

  6. Blood Measures

    microRNA levels in blood will be measured

    Measured: at pre-testing, 1-week post discharge and 4-week post discharge

  7. 30 day re-hospitalization

    re-hospitalization rates will be collected

    Measured: 30 days post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2014 (estimated)
  2. Study startOct 2013
  3. Primary completionJul 2016
  4. Study completionDec 2017

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02203656
Sponsor's protocol ID
13-038
Other IDs
1229
Acronym
PACE
Status last verified
Dec 2017
First submitted
22 May 2014
Last updated
4 Apr 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No: No. This is a small Phase 1 pre-pilot study. Risk of loss of confidentiality

Publications

  • Deer RR, Dickinson JM, Fisher SR, Ju H, Volpi E. Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial. Contemp Clin Trials. 2016 Jul;49:6-14. doi: 10.1016/j.cct.2016.05.001. Epub 2016 May 10.

    PubMed 27178766

  • Deer RR, Goodlett SM, Fisher SR, Baillargeon J, Dickinson JM, Raji M, Volpi E. A Randomized Controlled Pilot Trial of Interventions to Improve Functional Recovery After Hospitalization in Older Adults: Feasibility and Adherence. J Gerontol A Biol Sci Med Sci. 2018 Jan 16;73(2):187-193. doi: 10.1093/gerona/glx111.

    PubMed 28591764

  • Deer RR, Dickinson JM, Baillargeon J, Fisher SR, Raji M, Volpi E. A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1628-1636. doi: 10.1093/gerona/glz084.

    PubMed 30906944

  • Arentson-Lantz EJ, Deer RR, Kokonda M, Wen CL, Pecha TA, Carreon SA, Ngyen TM, Volpi E, Nowakowski S. Improvements in sleep quality and fatigue are associated with improvements in functional recovery following hospitalization in older adults. Front Sleep. 2022;1:1011930. doi: 10.3389/frsle.2022.1011930. Epub 2022 Oct 14.

    PubMed 37251511

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nutritional Supplement, In-home exercise and Testosterone in people with Aging, run by The University of Texas Medical Branch, Galveston at 2 sites 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 8 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score (time frame: at pre-testing, 1-week post discharge and 4-week post discharge). 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 NCT02203656, which also lists 4 linked publications.

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 4 Apr 2019; AzTrials last refreshed its copy on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in