Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03473990
Other study ID # C16122016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2017
Est. completion date October 1, 2019

Study information

Verified date August 2020
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will aim to evaluate the efficacy of a short-term, home-based, high-intensity interval (HIT) programme in improving cardiovascular fitness in healthy volunteers aged 55 and above, with an age-comparison to younger individuals taking part in the same training regime.

It will also explore the efficacy of time-matched 'static' interventions for improving cardiovascular parameters in middle-aged females and older adults.


Description:

Patients with lower peak oxygen uptake have higher mortality and morbidity when undergoing major surgery. Aerobic fitness is a potentially modifiable risk factor for postoperative complications.

Traditional pre-operative exercise interventions to improve fitness involve high time and supervision-demands, often resulting in poor compliance. High-intensity interval training (HIT) is a time-efficient, feasible method to improve pre-operative fitness, however current studies only involve exercise in the laboratory setting.

Study Design Thirty-six healthy volunteers aged 55y and over will be randomly allocated to one of three groups: 1) Laboratory-HIT; 2) Home-HIT; 3) No intervention. All HIT sessions will involve a brief warm-up, followed by five 1-minute bouts of high-intensity (body-weight based) exercise, interspersed with 90-seconds recovery, concluding with a brief cool-down. The primary endpoint of the study is change in VO2 peak with secondary endpoints of changes in: anaerobic threshold, insulin sensitivity and muscle mass.

Subjects will be expected to perform up to a maximum of 16 HIT sessions (maximum 5 sessions per week) within a period of 31 days. Aerobic fitness will be assessed prior to and following the exercise, as will body composition, muscle structure, physical function and insulin sensitivity.

For the age comparison, 24 young individuals will be recruited to either a control or home-HIT arm.

In addition, the efficacy of time-matched 'static' interventions for improving cardiovascular parameters in 24 middle-aged females will also be assessed as exploratory work for these interventions.

The efficacy of the static interventions in older adults at home will also be explored.

Power calculation: The investigators performed a power calculation for the primary outcome of VO2 max in older adults using data from a previous study at our centre on home versus laboratory HIIT. Assuming an effect size F of 0.6 for three groups and a within group SD of 5, the alpha level was set at 0.05 and the 1-beta at 0.80. This concluded that 30 participants would be required. To allow for potential non-completion and missing data 36 older participants will be enrolled to the study (12 to each group).


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date October 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

Age > 55 years Able to give informed consent

Exclusion Criteria:

- Current participation in a formal exercise regime

- A BMI < 18 or > 35 kg·m2

- Active cardiovascular disease:

- Uncontrolled hypertension (BP > 160/100)

- Angina

- Heart failure (class III/IV)

- Significant arrhythmia

- Right to left cardiac shunt

- Recent cardiac event

- Taking beta-adrenergic blocking agents

- Cerebrovascular disease:

- Previous stroke

- Aneurysm (large vessel or intracranial)

- Epilepsy

- Respiratory disease including:

- Pulmonary hypertension

- Significant COPD

- Uncontrolled asthma

- Malignancy

- Metabolic disease e.g. diabetic patients

- Clotting dysfunction

- Significant Musculoskeletal or neurological disorders

- Family history of early (<55y) death from cardiovascular disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High-intensity interval training
2 minute warm up, followed by 5x1min HIT intervals separated by 90 seconds active recovery (walking on the spot) and then a 2 minute recovery period. The high intensity bouts will be a pyramid of exercises (star jumps, mountain climbers and on-the-spot sprints)

Locations

Country Name City State
United Kingdom The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, Royal Derby Hospital Derby

Sponsors (1)

Lead Sponsor Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in VO2 Max (L/min) assessed by Cardio-pulmonary exercise test (CPET) To determine the efficacy of bodyweight HIT for improving aerobic fitness 31 days
Secondary Change in Anaerobic Threshold (L/min) using CPET To determine the efficacy of bodyweight HIT for improving aerobic fitness 31 days
Secondary Change in resting glucose and insulin sensitivity (mmol/L) The effects of HIT on improving glucose control using Oral Glucose Tolerance Test (OGTT) and enzyme-linked immunosorbent assay (ELISA) 31 days
Secondary Change in muscle architecture as assessed by ultrasound To assess the effects of HIT on improving muscle structure and function 31 days
Secondary Change in body composition (fat, muscle, bone (g)) as assessed by Dual-energy Xray Absorptiometry (DEXA) To assess the effects of HIT on improving muscle structure and function 31 days
Secondary Feasibility of home HIT assessed using a preset feasibility questionnaire To assess the feasibility and acceptability of performing a HIT programme at home 31 days
See also
  Status Clinical Trial Phase
Recruiting NCT05945641 - Effect of Low-load Resistance Training vs. High-intensity Interval Training on Local Muscle Endurance N/A
Completed NCT04084535 - Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea. N/A
Completed NCT06262256 - Effects of High-intensity Interval Training on Myocardial Strain in Metabolic Syndrome Patients N/A
Completed NCT04277091 - Upper-body High-intensity Interval Training and Mixed Meal Responses N/A
Recruiting NCT06108986 - Tabata vs Plyometric Training on Range of Motion, Agility and Vertical Jump in Taekwondo Players N/A
Recruiting NCT05562414 - Transient and Immediate Motor Effects of Exercise in Progressive Multiple Sclerosis N/A
Completed NCT06208761 - Triphala Supplementation and High-intensity Interval Exercise and Immune System Function and Oxidative Stress Phase 2
Completed NCT02759432 - Effect of a 4-week Fun Fast Interval Training (FFIT) Activity Programme on Physical Fitness and Quality of Life in Adolescent School Pupils N/A
Completed NCT05988606 - Work Rate Adjustments During a High-intensity Interval Training on a Stationary Bike in a Hot and Temperate Environment N/A
Completed NCT05274542 - Acute Effect of Blood Flow Restricted High-Intensity Resistive Training N/A
Completed NCT03563456 - Development of Structured Exercise Program for T2DM Management N/A
Completed NCT04033523 - High-Intensity Interval Training Recuperates Capacity of Endogenous Thrombin Generation in Patients With Heart Failure N/A
Completed NCT03759951 - Hybrid Exercise Training for Health, Performance and Well-Being (DoIT II) N/A
Completed NCT03570424 - Whey Protein Support to Metabolic and Performance Adaptations in Response HIIT N/A
Completed NCT02626767 - Effect of Novel High-intensity Interval Training on Health and Fitness Outcomes in English Adolescents N/A
Completed NCT03159494 - High-intensity Training, Self-monitoring and Diabetes 2 N/A
Recruiting NCT05838950 - HIIT Effects on Cardiometabolic Health N/A
Completed NCT05513521 - Speed-specific Training and Ultrasound N/A
Recruiting NCT03593746 - Effects of High Intensity Interval Training and Combined Training in Type 2 Diabetic (T2D) Patients N/A
Completed NCT03467594 - BE@Work: Brief Exercise at Work N/A