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NCT Number: NCT06825130

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

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.

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Key information

Conditions

Older Adult

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

David Greenfield Humnn Physiology Unit (DGHPU), University of Nottingham

Nottingham, NG72UH, United Kingdom

Location status: Recruiting

Location contact

Tasuku Terada, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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.

Primary outcomes

  1. Feasibility of high-intensity interval training combined with muscle strength training

    Time frame: From recruitment to week-12

    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.

Secondary outcomes

  1. functional capacity

    Time frame: From baseline to week-12

    will be assessed using the Fullerton Functional Fitness Test, a valid and reliable measure of functional independence in older adults

  2. muscle function

    Time frame: From baseline to week-12

    Isometric strength, isokinetic muscle torque (i.e., strength) and fatigue will be measured using a dynamometer (CYBEX).

  3. cardiorespiratory fitness

    Time frame: From baseline to week-12

    will be measured by a gold-standard, symptom-limited CPET using metabolic equipment on an electronically braked cycle ergometer.

  4. muscle mass

    Time frame: From baseline to week-12

    will be measured using ultrasound at the mind-point of the thigh, from the greater trochanter to mid patella.

  5. QoL

    Time frame: From baseline to week-12

    will be assessed using Short Form 36 Health Survey Questionnaire (SF-36).

Study contacts

Contact information is provided by the study sponsor or research team.

Tasuku Terada, PhD

CONTACT

[email protected]

441158230141

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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