NCT05790863

Brief Summary

Background: Sarcopenia is an age-related geriatric syndrome characterized by progressive loss of muscle mass and function. Before the diagnosis of sarcopenia, a "possible sarcopenia" stage has been proposed recently, characterized by low muscle strength or poor physical performance, even with normal muscle mass. The definition of "possible sarcopenia" emphasizes the importance of early intervention. Due to the lack of effective pharmaceutical treatments, exercise is recommended as the most available intervention for sarcopenia. High-intensity interval training (HIIT), a time-efficient aerobic training, has gained increasing popularity for its benefits in physiologic outcomes such as muscle strength and physical functions in other populations. However, the benefits of HIIT have not been well-studied following older adults with possible sarcopenia. In the present study, we aim to investigate the effects of a 7-week HIIT and moderate-intensity continuous aerobic training (MICT) on physical performance in older individuals with possible sarcopenia. We hypothesize that HIIT will confer physical benefits over MICT (i.e., traditional endurance exercise) and will be generally well-tolerated in older adults. Method: The participants will be randomly allocated into the HIIT or MICT group (1:1 ratio). The participants will receive the training 3 times per week over seven weeks. HIIT consists of 5 bouts of interval training intensity with 1-minute-high intensity (76-90% HRmax) and 1-minute recovery per session (total 15 minutes with warm-up and cool-down). MICT will adopt an intensity of 65-70% HRmax training that lasts less than 30 minutes per session (total 25 minutes with warm-up and cool-down). Evaluation will be performed at baseline, after 4 weeks, and 7 weeks of the intervention. The primary outcomes include 10-meter walking test and the five-time chair stand test. The secondary outcomes include grip strength, the functional stretch test; the Exercise Enjoyment Scale and the Physical Activity Enjoyment Scale for affective valence. Discussion: This is the first study to investigate the effects of low-volume HIIT on physical performance and affective valence in older adults with possible sarcopenia. This study will provide critical evidence to guide early prevention and intervention of exercise regimens for possible sarcopenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 7, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

July 22, 2025

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

March 2, 2023

Last Update Submit

July 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in time of the The 5 repeated sit-to-stand test after 7 weeks of intervention

    The 5 repeated sit-to-stand test is a validated way to reflect the lower limb muscle strength and balance ability of the elderly. Subjects are required to complete 5 times of standing up and sitting down as fast as possible without using handrails or other assistance by crossing the arms in front of the chest. Care should be taken to ensure that the knee joints are completely straight before sitting down. The time of completing test will be recorded. Change=(week 7 time- baseline time)

    Baseline and after 7 weeks of intervention

Secondary Outcomes (5)

  • Change from Baseline in walking speed of the 10 meter-walk test after 7 weeks of intervention

    Baseline and after 7 weeks of intervention

  • Change from Baseline in Hand grip strength after 7 weeks of intervention

    Baseline and after 7 weeks of intervention

  • Change from Baseline in distance of The functional stretch test after 7 weeks of intervention

    Baseline and after 7 weeks of intervention

  • Change from Baseline in score of The Exercise Enjoyment Scale after 7 weeks of intervention

    Baseline and after 7 weeks of intervention

  • Change from Baseline in score of The Physical activity enjoyment scale after 7 weeks of intervention

    Baseline and after 7 weeks of intervention

Study Arms (2)

High-intensity interval training group

EXPERIMENTAL

Each ergometer cycling training session consists of a warm-up phase lasting two minutes, five interval bouts of one minute each at 77% to 90% of one's HRmax, separated by one minute of passive or low-intensity recovery, and a three-minute cool-down phase. After 4 weeks of the intervention, the minimal intensity that had to be met will be progressively raised (weeks 1-4: 76-85%, weeks 5-7: 85-90%HRmax, respectively). For individuals who are unable to reach 77% HRmax, scores of 15 to 17 (hard to very hard) on the Borg scale will be followed.

Device: Ergometer cycling

Moderate-intensity continuous training group

ACTIVE COMPARATOR

During the first four weeks, participants will be advised to modify the pedal cadence and/or resistance of the ergometer to obtain an HR equivalent to 65-70% HRmax, rising to 70-76% HRmax during the final 3 weeks. Each session lasts less than 25 minutes of moderate-intensity continuous ergometer cycling, which starts with a two-minute warm-up and ends up with a three-minute cool-down.

Device: Ergometer cycling

Interventions

Paticipants will receive 21 sessions (3 sessions/week) of training for 7 weeks with the arm-leg cycle ergometer (SCIFIT, REX7000, US)

High-intensity interval training groupModerate-intensity continuous training group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • individuals aged 60 years or older, living in the community
  • Able to walk with or without assistive devices
  • Recovery from COVID-19 over two months
  • With a preliminary screening of SARC-F score ≥4 or calf circumference less than 34cm for man, 33cm for woman will be invited to strength and physical performance measurement
  • Handgrip strength less than 28 kg for man, 18 kg for woman and/or gait speed\<1m/s and/or 5-time chair stand test ≥12 s.

You may not qualify if:

  • Inability to undertake exercise due to neuromuscular and/or musculoskeletal limitations
  • Uncontrolled hypertension (systolic BP\>170 or diastolic BP\>100 mmHg)
  • Reported chronic cardiopulmonary insufficiency in medical history
  • Reported vital organ failure and malignancy in medical history
  • Cognitive impairments (mini-mental test score\<21) with low compliance
  • History of lower limb surgeries, fractures, neurological problems, systemic problems, and any other contraindications for aerobic training will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Brain Hospital

Wuhan, Hubei, 430000, China

Location

Related Publications (9)

  • Reljic D, Frenk F, Herrmann HJ, Neurath MF, Zopf Y. Effects of very low volume high intensity versus moderate intensity interval training in obese metabolic syndrome patients: a randomized controlled study. Sci Rep. 2021 Feb 2;11(1):2836. doi: 10.1038/s41598-021-82372-4.

    PMID: 33531522BACKGROUND
  • Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

    PMID: 32033882BACKGROUND
  • Rosenberg IH. Sarcopenia: origins and clinical relevance. J Nutr. 1997 May;127(5 Suppl):990S-991S. doi: 10.1093/jn/127.5.990S.

    PMID: 9164280BACKGROUND
  • Dent E, Morley JE, Cruz-Jentoft AJ, Arai H, Kritchevsky SB, Guralnik J, Bauer JM, Pahor M, Clark BC, Cesari M, Ruiz J, Sieber CC, Aubertin-Leheudre M, Waters DL, Visvanathan R, Landi F, Villareal DT, Fielding R, Won CW, Theou O, Martin FC, Dong B, Woo J, Flicker L, Ferrucci L, Merchant RA, Cao L, Cederholm T, Ribeiro SML, Rodriguez-Manas L, Anker SD, Lundy J, Gutierrez Robledo LM, Bautmans I, Aprahamian I, Schols JMGA, Izquierdo M, Vellas B. International Clinical Practice Guidelines for Sarcopenia (ICFSR): Screening, Diagnosis and Management. J Nutr Health Aging. 2018;22(10):1148-1161. doi: 10.1007/s12603-018-1139-9.

    PMID: 30498820BACKGROUND
  • Lozano-Montoya I, Correa-Perez A, Abraha I, Soiza RL, Cherubini A, O'Mahony D, Cruz-Jentoft AJ. Nonpharmacological interventions to treat physical frailty and sarcopenia in older patients: a systematic overview - the SENATOR Project ONTOP Series. Clin Interv Aging. 2017 Apr 24;12:721-740. doi: 10.2147/CIA.S132496. eCollection 2017.

    PMID: 28490866BACKGROUND
  • Buchheit M, Laursen PB. High-intensity interval training, solutions to the programming puzzle. Part II: anaerobic energy, neuromuscular load and practical applications. Sports Med. 2013 Oct;43(10):927-54. doi: 10.1007/s40279-013-0066-5.

    PMID: 23832851BACKGROUND
  • Hannan AL, Hing W, Simas V, Climstein M, Coombes JS, Jayasinghe R, Byrnes J, Furness J. High-intensity interval training versus moderate-intensity continuous training within cardiac rehabilitation: a systematic review and meta-analysis. Open Access J Sports Med. 2018 Jan 26;9:1-17. doi: 10.2147/OAJSM.S150596. eCollection 2018.

    PMID: 29416382BACKGROUND
  • Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.

    PMID: 10380242BACKGROUND
  • Mehmet H, Yang AWH, Robinson SR. What is the optimal chair stand test protocol for older adults? A systematic review. Disabil Rehabil. 2020 Oct;42(20):2828-2835. doi: 10.1080/09638288.2019.1575922. Epub 2019 Mar 24.

    PMID: 30907166BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 30, 2023

Study Start

March 7, 2023

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

July 22, 2025

Record last verified: 2024-12

Locations