NCT03331679

Brief Summary

The incidence of conditions requiring surgical intervention increases with age, however there is a reported decline in the rates of elective surgical procedures in those over 65. This is associated with older patients being described as "less fit" and more at risk of postoperative complications, leading to decreased provision of surgical care to those at need. Exercise interventions have the potential to reverse some of the decline in cardiovascular fitness associated with aging and improve the elderly's' "fitness for surgery" and potentially allow increased access to surgical care for those most in need of it.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

October 27, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 23, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

October 27, 2017

Last Update Submit

March 8, 2019

Conditions

Cardiorespiratory Fitness

Outcome Measures

Primary Outcomes (1)

  • Anaerobic Threshold

    Anaerobic Threshold as measured at standard CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)

    2 weeks

Secondary Outcomes (5)

  • VO2 Peak

    2 Weeks

  • Whole-Body Lean Mass

    2 Weeks

  • Body Fat percentage

    2 Weeks

  • Leg Lean Mass

    2 Weeks

  • Handgrip Strength

    2 Weeks

Study Arms (1)

2 Wk HIIT

EXPERIMENTAL

2 weeks of High Intensity Interval Training

Behavioral: HIIT

Interventions

HIITBEHAVIORAL

2 Weeks of High Intensity Interval Training on a Cycle ergometer

2 Wk HIIT

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy Volunteer aged 65-85

You may not qualify if:

  • Current participation in a formal exercise regime
  • BMI \< 18 or \> 32 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, Metabolic disease: -hyper and hypo parathyroidism, -untreated hyper and hypothyroidism, Cushing's disease, type 1 or 2 diabetes
  • Active inflammatory bowel or renal disease
  • Malignancy
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School

Derby, DE22 3DT, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2017

First Posted

November 6, 2017

Study Start

January 23, 2018

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

GB(1)