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
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2025
CompletedFirst Submitted
Initial submission to the registry
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
February 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 13, 2025
February 1, 2025
1.6 years
February 3, 2025
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
functional capacity
From baseline to week-12
muscle function
From baseline to week-12
cardiorespiratory fitness
From baseline to week-12
muscle mass
From baseline to week-12
QoL
From baseline to week-12
Study Arms (2)
aerobic training + muscle strength training
EXPERIMENTAL3 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.
aerobic training
ACTIVE COMPARATOR3 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
David Greenfield Humnn Physiology Unit (DGHPU), University of Nottingham
Nottingham, Nottingham, NG72UH, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 3, 2025
First Posted
February 13, 2025
Study Start
February 1, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 13, 2025
Record last verified: 2025-02