NCT06825130

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

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress66%
Feb 2025Dec 2026

Study Start

First participant enrolled

February 1, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

February 3, 2025

Last Update Submit

February 7, 2025

Conditions

Keywords

WomenHIITResistance exerciseCombined exercise

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

EXPERIMENTAL

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

aerobic training

ACTIVE COMPARATOR

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

Interventions

ExerciseBEHAVIORAL

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.

aerobic trainingaerobic training + muscle strength training

Eligibility Criteria

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

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

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Locations