NCT05934760

Brief Summary

The goal of this interventional study is to learn about the role of mitochondrial function in healthy aging, and then go on and assess the role of a home-based exercise program on the changes seen. The main question\[s\] it aims to answer are:

  • What alterations in skeletal muscle mitochondrial function are seen in healthy aging?
  • Can a short-term exercise program alter these alterations seen? The older participants will be invited to take part in a home-based 4 week exercise intervention involving either:
  • High intensity interval training
  • Resistance based training (resistance bands will be provided) Researchers will compare the two exercise groups to see if it alters mitochondrial function.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 17, 2019

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

June 28, 2023

Last Update Submit

November 29, 2023

Conditions

Keywords

ExerciseMitochondrial functionHealthy Aging

Outcome Measures

Primary Outcomes (3)

  • Mitochondrial activity across age

    Mitochondrial oxidative phosphorylation capacity changes seen across the age groups investigated Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. This will then be compared across ages and expressed as a ratio of maximal consumption.

    This will be compared across baseline assessment dates in all ages.

  • Mitochondrial activity change with a short-term home-based exercise program in older participants

    The effect of either a resistance exercise-based and high-intensity interval training-based home-based training program on mitochondrial function in those over aged 60 Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. The changes seen throughout the treatment will then be expressed as a percentage in order to express the changes seen from the baseline.

    Assessed prior to and after the completion of a 4 week exercise program

  • The altered response to training type

    The differing responses to either high intensity interval training or resistance based training Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. The changes caused by the training regimen will then be expressed as a percentage in order to express the changes seen from the baseline, and in order to allow comparison between training modality.

    4 weeks

Study Arms (2)

High intensity interval training (HIIT)

EXPERIMENTAL

Older participants (over 60) will be randomized to perform home-based unsupervised exercise, the HIIT group will perform the HIIT intervention 3 times a week, at home, unsupervised for 4 weeks. This will be supported by regular contact from a member of the research team to provide support and to encourage adherance. Our research group has conducted many similar exercise regimes of this intensity to subjects in the anticipated age-range without incident. Participants will be adviced to terminate exercise training immediately if experiencing: * Chest pain or tightness * Faintness * Sudden pallor * Loss of co-ordination * Confusion * Dizziness * Palpitations * Sudden breathlessness Should any participant experience these effects during any session, they will be advised to seek urgent medical attention and will be withdrawn from the exercise arm of the study for safety purposes.

Other: High intensity interval training (HIIT)

Resistance exercise training (RET)

EXPERIMENTAL

Older participants (over 60) will be randomized to perform home-based unsupervised exercise, the RET group will perform the RET intervention at home, 3 times a week unsupervised for 4 weeks.This will be supported by regular contact from a member of the research team to provide support and to encourage adherance. Our research group has conducted many similar exercise regimes of this intensity to subjects in the anticipated age-range without incident. Participants will be adviced to terminate exercise training immediately if experiencing: * Chest pain or tightness * Faintness * Sudden pallor * Loss of co-ordination * Confusion * Dizziness * Palpitations * Sudden breathlessness Should any participant experience these effects during any session, they will be advised to seek urgent medical attention and will be withdrawn from the exercise arm of the study for safety purposes.

Other: Resistance based training (RET)

Interventions

Each HIIT session last 15 minutes. Participants will be asked to measure their own heart rate during their rest periods and provided with an estimated max heart rate which they should be aiming to achieve within the final 2 exercises. Participants will be provided with a logbook to record the heart rate achieved in each exercise. The regimen will include: * 2 min warm-up: jogging on the spot * Each of the following exercises performed for 60seconds, interspaced by 90 seconds rest * Star jumps * Standing squats * On-the-spot sprints * Standing squats * Star jumps * 2 min cool-down: jogging on the spot

High intensity interval training (HIIT)

Each RET session lasts an estimated 20minutes. Participants will be provided with a set of resistance bands to provide resistance to their workout, and a logbook to record the number of repetitions and band used. Each session will include: * 2 min warm-up jogging on the spot * 2 sets of 12-15 repetitions of: * Squats * Hip flexion * Hip extension * Hip abduction * Seated row * Bench press * Lateral raises * 2 min jogging on the spot cooldown. Each exercise will be separated by 1-minute rest, with participants encouraged to workout to mild fatigue on their final repetition in each set. If able to perform more than the allocated maximum of 15 repetitions prior to fatigue, then participants will be informed to increase the resistance by using a tougher resistance band.

Resistance exercise training (RET)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ● Healthy male or female aged over 18 years old able to give informed, written consent.

You may not qualify if:

  • ● Current participation in a formal exercise regime
  • Inability to use a static exercise bike
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate Entry Medical School, University of Nottingham, Royal Derby Hospital

Derby, Derbyshire, DE223NE, United Kingdom

Location

MeSH Terms

Conditions

SarcopeniaMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of exercise interventions, it is not possible to blind the participants or investigators.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 7, 2023

Study Start

December 17, 2019

Primary Completion

December 30, 2023

Study Completion

March 30, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations