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Effects of Low-volume HIIT Versus MICT on Physical Performance in Older Adults With Possible Sarcopenia

Primary Purpose

Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ergometer cycling
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Wuhan Brain HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity interval training group

Moderate-intensity continuous training group

Arm Description

Each ergometer cycling training session consists of a warm-up phase lasting two minutes, five interval bouts of one minute each at 76% 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 76% HRmax, scores of 15 to 17 (hard to very hard) on the Borg scale will be followed.

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 70-75% HRmax during the final 3 weeks. Each session lasts less than 30 minutes of moderate-intensity continuous ergometer cycling, which starts with a two-minute warm-up and ends up with a three-minute cool-down.

Outcomes

Primary Outcome Measures

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)
Change from Baseline in walking speed of the 10 meter-walk test after 7 weeks of intervention
A 10-meter track needs to be marked before measurement, with separate markers at 2 meters and 8 meters. Timing starts when the subject's front foot crosses the 2-meter marker and ends at 8 meters. Subjects will be allowed to use walking aids, but no assistance will be allowed. Three tests will be performed with a 1-minute break in between; the average walking speed will be calculated. Change=(week 7 speed- baseline speed)

Secondary Outcome Measures

Change from Baseline in Hand grip strength after 7 weeks of intervention
Subjects will be instructed to take a seat measurement with their arm extended, forearm unsupported, elbow flexed at 90 degrees, wrist in a neutral position, and grip tightened to maximum capacity by using a Jamar dynamometer. The dominant hand will perform the grip strength twice, and the maximum force will be recorded. Change=(week 7 strength- baseline stength)
Change from Baseline in distance of The functional stretch test after 7 weeks of intervention
The subject stands sideways against the wall with the arm elevated and parallel, reaches forward as far as possible with the body balanced, keeping the feet unmoving. The distance of forward extension reach of the middle finger end position will be measured twice, with a rest interval of 1 minute, and the average value will be obtained. Change=(week 7 score- baseline score)
Change from Baseline in score of The Exercise Enjoyment Scale after 7 weeks of intervention
EES is a single-item 7-point scale with the following instruction: "Please measure how much you are enjoying the current exercise." It ranges from "1" (not at all enjoyable) to "7" (extremely enjoyable) Change=(week 7 score- baseline score)
Change from Baseline in score of The Physical activity enjoyment scale after 7 weeks of intervention
PACES has 18 different items on a 7-point scale, is used to quantify post-exercise satisfaction (e.g., "1" I enjoyed the sport, "7" I hated the sport). "Please rate how you feel about the activity you just completed" is the directive. Change=(week 7 score- baseline score)

Full Information

First Posted
March 2, 2023
Last Updated
March 16, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT05790863
Brief Title
Effects of Low-volume HIIT Versus MICT on Physical Performance in Older Adults With Possible Sarcopenia
Official Title
Effects of Low-volume High-intensity Training Versus Moderate-intensity Continuous Training on Physical Performance in Older Adults With Possible Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training group
Arm Type
Experimental
Arm Description
Each ergometer cycling training session consists of a warm-up phase lasting two minutes, five interval bouts of one minute each at 76% 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 76% HRmax, scores of 15 to 17 (hard to very hard) on the Borg scale will be followed.
Arm Title
Moderate-intensity continuous training group
Arm Type
Active Comparator
Arm Description
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 70-75% HRmax during the final 3 weeks. Each session lasts less than 30 minutes of moderate-intensity continuous ergometer cycling, which starts with a two-minute warm-up and ends up with a three-minute cool-down.
Intervention Type
Device
Intervention Name(s)
Ergometer cycling
Intervention Description
Paticipants will receive 21 sessions (3 sessions/week) of training for 7 weeks with the arm-leg cycle ergometer (SCIFIT, REX7000, US)
Primary Outcome Measure Information:
Title
Change from Baseline in time of the The 5 repeated sit-to-stand test after 7 weeks of intervention
Description
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)
Time Frame
Baseline and after 7 weeks of intervention
Title
Change from Baseline in walking speed of the 10 meter-walk test after 7 weeks of intervention
Description
A 10-meter track needs to be marked before measurement, with separate markers at 2 meters and 8 meters. Timing starts when the subject's front foot crosses the 2-meter marker and ends at 8 meters. Subjects will be allowed to use walking aids, but no assistance will be allowed. Three tests will be performed with a 1-minute break in between; the average walking speed will be calculated. Change=(week 7 speed- baseline speed)
Time Frame
Baseline and after 7 weeks of intervention
Secondary Outcome Measure Information:
Title
Change from Baseline in Hand grip strength after 7 weeks of intervention
Description
Subjects will be instructed to take a seat measurement with their arm extended, forearm unsupported, elbow flexed at 90 degrees, wrist in a neutral position, and grip tightened to maximum capacity by using a Jamar dynamometer. The dominant hand will perform the grip strength twice, and the maximum force will be recorded. Change=(week 7 strength- baseline stength)
Time Frame
Baseline and after 7 weeks of intervention
Title
Change from Baseline in distance of The functional stretch test after 7 weeks of intervention
Description
The subject stands sideways against the wall with the arm elevated and parallel, reaches forward as far as possible with the body balanced, keeping the feet unmoving. The distance of forward extension reach of the middle finger end position will be measured twice, with a rest interval of 1 minute, and the average value will be obtained. Change=(week 7 score- baseline score)
Time Frame
Baseline and after 7 weeks of intervention
Title
Change from Baseline in score of The Exercise Enjoyment Scale after 7 weeks of intervention
Description
EES is a single-item 7-point scale with the following instruction: "Please measure how much you are enjoying the current exercise." It ranges from "1" (not at all enjoyable) to "7" (extremely enjoyable) Change=(week 7 score- baseline score)
Time Frame
Baseline and after 7 weeks of intervention
Title
Change from Baseline in score of The Physical activity enjoyment scale after 7 weeks of intervention
Description
PACES has 18 different items on a 7-point scale, is used to quantify post-exercise satisfaction (e.g., "1" I enjoyed the sport, "7" I hated the sport). "Please rate how you feel about the activity you just completed" is the directive. Change=(week 7 score- baseline score)
Time Frame
Baseline and after 7 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Wang, DHSc student
Phone
8618627812097
Email
wayne-quan.wang@connect.polyu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Meizhen Huang, PHD
Email
mei-zhen.huang@polyu.edu.hk
Facility Information:
Facility Name
Wuhan Brain Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Wang, Master
Phone
8618627812097
Email
kbwangquan@163.com

12. IPD Sharing Statement

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Effects of Low-volume HIIT Versus MICT on Physical Performance in Older Adults With Possible Sarcopenia

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