NCT03473990

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

October 31, 2017

Last Update Submit

August 12, 2020

Conditions

High-Intensity Interval Training

Keywords

Home-basedShort-termRandomised Control Trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Anaerobic Threshold (L/min) using CPET

    31 days

  • Change in resting glucose and insulin sensitivity (mmol/L)

    31 days

  • Change in muscle architecture as assessed by ultrasound

    31 days

  • Change in body composition (fat, muscle, bone (g)) as assessed by Dual-energy Xray Absorptiometry (DEXA)

    31 days

  • Feasibility of home HIT assessed using a preset feasibility questionnaire

    31 days

Study Arms (3)

Laboratory HIT

ACTIVE COMPARATOR

Supervised (Laboratory HIT) exercise in the lab up to 4 times per week for 4 weeks

Other: High-intensity interval training

Home HIT

ACTIVE COMPARATOR

Unsupervised (Home HIT) exercise at home up to 4 times per week for 4 weeks

Other: High-intensity interval training

Control Group

NO INTERVENTION

No intervention

Interventions

High-intensity interval trainingOTHER

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)

Also known as: HIT
Home HITLaboratory HIT

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 55 years Able to give informed consent

You may not qualify if:

  • 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:
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, Royal Derby Hospital

Derby, DE22 3DT, United Kingdom

Location

Related Publications (1)

  • Sian TS, Inns TB, Gates A, Doleman B, Bass JJ, Atherton PJ, Lund JN, Phillips BE. Equipment-free, unsupervised high intensity interval training elicits significant improvements in the physiological resilience of older adults. BMC Geriatr. 2022 Jun 28;22(1):529. doi: 10.1186/s12877-022-03208-y.

    PMID: 35761262DERIVED

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bethan Philips

    The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, Royal Derby Hospital, Derby, DE22 3DT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 31, 2017

First Posted

March 22, 2018

Study Start

October 3, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

August 17, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Non-identifiable participant data will be made available for all outcome measures

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Duration of PhD (3 years)
Access Criteria
Password protected database only given to researchers with special access to the database

Locations

GB(1)