Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training

NCT03750006 | Terminated Results

• 2 other identifiers: E2902-PRX002902
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty is a clinical condition of poor physiological reserve that increases risks for adverse health outcomes including falls, hospitalization and mortality. Exercise is beneficial for the prevention and even reversal of frailty, yet participation among older individuals is limited. Short session high intensity interval training (HIIT) is emerging as a promising exercise strategy that achieves performance gains with lower time commitment. The goal of this pilot proposal is to establish the feasibility of HIIT exercise training protocols in 65-85 year old individuals, as well as to demonstrate the ability to detect functional and physiologic benefits. The investigators anticipate the preliminary research findings will lay the foundation for future human clinical studies that will permit us to significantly improve the health of Veterans.

Conditions

Frailty

Keywords

frailty; sarcopenia; exercise; high intensity; older adults; microRNA

Outcome Measures

Primary Outcomes (3)

• 6-minute Walk at Baseline and Endpoint

  6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace.

  baseline and at participant completion, an average of 3 months

• Physical Activity Enjoyment at Baseline and Endpoint

  Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 questions, each of which can receive a score from 1 to 7, where 7 is represents greater enjoyment. Scores presented as the mean across all questions giving an overall range of 1-7.

  baseline and at participant completion, an average of 3 months

• VO2max at Baseline and Endpoint

  Performed as part of a symptom limited maximal endurance test on a cycle ergometer

  baseline and at participant completion, an average of 3 months

Secondary Outcomes (13)

• Short Physical Performance Battery at Baseline and Endpoint

  baseline and at participant completion, an average of 3 months

• Frailty at Baseline and Endpoint

  baseline and at participant completion, an average of 3 months

• Quality of Life Survey at Baseline and Endpoint

  baseline and at participant completion, an average of 3 months

• Cognitive Survey at Baseline and Endpoint

  baseline and at participant completion, an average of 3 months

• Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint

  baseline and at participant completion, an average of 3 months

Study Arms (1)

HIIT intervention

EXPERIMENTAL

Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.

Behavioral: Short session HIIT

Interventions

Short session HIIT BEHAVIORAL

Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.

HIIT intervention

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Any race
• Frail, pre-frail, and non-frail
• Medical clearance for exercise

You may not qualify if:

• Severe co-morbidity (e.g. - CHF (class III), COPD (GOLD stage IV), CKD (stage 3))
• VAMC SLUMS score 20
• Physical impairment that prevents use of a recumbent exercise bike

Sponsors & Collaborators

• VA Office of Research and Development: lead
• The VA Western New York Healthcare System: collaborator
• University at Buffalo: collaborator
• Roswell Park Cancer Institute: collaborator

Study Sites (1)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Frailty; Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Behavior

Limitations and Caveats

Goal of trial was to evaluate recruitment, administration, and safety profile of short session HIIT, and not necessarily the efficacy of the HIIT protocol for functional capacity. Trial does not have a non-exercise control group Trial features limited number of participants (23), which includes only 1 female Trial was stopped short due to COVID-19 pandemic, 8 of the 23 participants did not complete the total 12 weeks of training although all participants had at least 6 weeks of training.

Results Point of Contact

• Title: Bruce Troen
• Organization: VA Kansas City Healthcare System

bruce.troen@va.gov

913-574-4896

Study Officials

• Bruce R. Troen, MD

  VA Western New York Healthcare System, Buffalo, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The goals of this proposal are to: 1) investigate the feasibility of recruiting and administering short session HIIT to frail, pre-frail, and non-frail older Veterans and 2) to characterize the physical performance benefits and serum microRNA (miRNA) profiles in those participants.

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 21, 2018
• Study Start: December 3, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: August 30, 2024
• Results First Posted: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Six months after publication.
• Access Criteria: Final data sets will be made available upon specific request and under an authorized Data Use Agreement. This, in addition to the publications being made available via PubMed Central, will enable validation of results by recipients.

Locations

US (1)