High-intensity Interval Training Combined with Muscle-strength Training in Older Women

Feasibility and Preliminary Efficacy of High-intensity Interval Training Combined with Muscle-strength Training in Older Women: Pilot Randomized Controlled Trial

Women generally live longer than men but often experience a faster muscle mass loss due to inactivity, which can lead to weakness and disability. Despite these risks, women, particularly older women, are less active than men. In England, less than one-third of women engage in sufficient aerobic activity, and less than 5% do enough muscle strength training. Common reasons for not exercising include lack of time and enjoyment.

High-intensity interval training (HIIT) is an efficient and effective way to exercise that many women find more enjoyable than longer workouts. HIIT has been shown to be effective in older women, helping them improve their fitness with less time commitment. Because HIIT is time-efficient, it can be combined with muscle strength training without significantly increasing the duration of the exercise session, which may lead to even better fitness results.

This study will assess how practical it is for older women to do HIIT and strength exercise combined training. It will also investigate whether this combined approach can improve overall fitness, muscle strength, aerobic fitness, and quality of life more than HIIT alone.

Study Overview

• Status: Recruiting
• Conditions: Older Adult
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tasuku Terada, PhD; Phone Number: 441158230141; Email: tasuku.terada@nottingham.ac.uk

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG72UH
    • Recruiting
    • David Greenfield Humnn Physiology Unit (DGHPU), University of Nottingham
    • Contact: Tasuku Terada, PhD; Email: tasuku.terada@nottingham.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Females (biologically at birth)
• At least 60 years of age at the time of signing the informed consent
• Non-smoker, including electronic cigarettes
• Not participating in routine high-intensity aerobic or muscle strength exercise training (≥ 75 min/week of structured vigorous aerobic exercise, or 2 times /week of structured muscle strength training)
• Able to perform a cardiopulmonary exercise testing (CPET) to exhaustion
• willing to complete baseline and follow-up measures, and attend prescribed exercise sessions at the University of Nottingham
• willing and able to give informed consent for participation in the study

Exclusion Criteria:

• Diagnosed with cardiovascular disease, kidney disease, diabetes, obstructive pulmonary disease, or uncontrolled hypertension
• History or current neurological or psychiatric illness, or motor or cognitive restrictions
• Contraindications to symptom-limited cardiopulmonary exercise testing (CPET), including resting hypertension with systolic blood pressure >200 mmHg or diastolic blood pressure > 110 mmHg, uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, and hyperthyroidism, mental impairment with limited ability to cooperate, physical disability that precludes safe and adequate testing.
• Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aerobic training + muscle strength training; 3 days/week -- 3-min warm up at 60% of HR@VT2 on a bike ergometer -- 6 x 1-min machine-base muscle strength exercises: leg press, chest press, knee extension, lat pull down, knee flexion, and shoulder raise -- 6 x 1-min high-intensity interval bouts at 80% HR@VT2 interspersed by 1-min active recovery will be performed.	Behavioral: Exercise; Participants will attend 30-min training sessions 3 times a week for 12 weeks. The intensity of HIIT will be at 80% HR@VT2 measured in the first week and will increase to 90% in the second week. By week 3, the intensity will reach HR@VT2.
Active Comparator: aerobic training; 3 days/week -- 3-min warm up at 60% of HR@VT2 on a bike ergometer -- 2 blocks of 6 x 1-min high-intensity interval bouts at 70% HR@VT2 interspersed by 1-min active recovery	Behavioral: Exercise; Participants will attend 30-min training sessions 3 times a week for 12 weeks. The intensity of HIIT will be at 80% HR@VT2 measured in the first week and will increase to 90% in the second week. By week 3, the intensity will reach HR@VT2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of high-intensity interval training combined with muscle strength training	will be assessed from recruitment, adherence, compliance, safety, subjective exercise experiences and self-efficacy. Recruitment will be assessed by the proportion of patients remained interested and randomized after being informed of the requirements of the study; adherence will be assessed by the attendance to the prescribed exercise sessions; and compliance will be assessed by the proportion of participants adhering to prescribed exercise intensity. For safety, all mild, moderate, and severe symptoms and adverse events throughout this study will be recorded.	From recruitment to week-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional capacity	will be assessed using the Fullerton Functional Fitness Test, a valid and reliable measure of functional independence in older adults	From baseline to week-12
muscle function	Isometric strength, isokinetic muscle torque (i.e., strength) and fatigue will be measured using a dynamometer (CYBEX).	From baseline to week-12
cardiorespiratory fitness	will be measured by a gold-standard, symptom-limited CPET using metabolic equipment on an electronically braked cycle ergometer.	From baseline to week-12
muscle mass	will be measured using ultrasound at the mind-point of the thigh, from the greater trochanter to mid patella.	From baseline to week-12
QoL	will be assessed using Short Form 36 Health Survey Questionnaire (SF-36).	From baseline to week-12

Collaborators and Investigators

• Sponsor: University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Women; Resistance exercise; HIIT; Combined exercise
• Other Study ID Numbers: FMHS 34-1124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No