Exercise TrainingNCT03645772
Plyometric Exercise to Improve Rapid Force Production in Older Men
A study testing Exercise intervention in people with Exercise Training, run by KU Leuven at 1 site in Belgium.
Trial summary
Rapid force production declines as a consequence of ageing. Given the functional relevance of rapid force production, exercise interventions in older adults should aim at improving the capacity to produce force rapidly. Read more about this study
- Who is it for?
- Ages 65 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Training
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Jan 2018to 19 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- -
Who cannot join
- No systematic engagement in (resistance) exercise in the 12-months prior to participation
- Cardiovascular disease
- Neurological disorders
- Cognitive malfunctioning
- Severe knee or hip problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plyometric Exercise to Improve Rapid Force Production in Older Men: a Pilot Intervention
Rapid force production declines as a consequence of ageing. Given the functional relevance of rapid force production, exercise interventions in older adults should aim at improving the capacity to produce force rapidly. To improve this capacity, exercises should be performed with the intention to develop high speeds, as supported by previous work.
Human locomotion fundamentally consists of multi-joint movements and rapidly coupled eccentric-concentric muscle actions, known as stretch-shortening cycle (SSC) activities or plyometrics. Plyometrics might therefore be used to optimize power production. However, there is limited research on the feasibility of plyometrics in older adults and its potential effects on rapid force production and functional capacity. This study will test the feasibility of a 12-week plyometric exercise intervention in older men and compare its effects on rapid force production to a traditional resistance exercise or walking intervention.
- Conditions
- Exercise Training
- Being tested
- Exercise intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week progressive training intervention
| Study group | Role | What they receive |
|---|---|---|
| Plyometric exercise | Experimental | 12-week progressive exercise program, consisting of plyometric exercises such as countermovement jump, forward and sideways step-up. Receives: Other: Exercise intervention |
| Resistance exercise | Active comparator | 12-week resistance exercise program for the leg muscles (2-4 sets of 8-15 repetitions at 8-15RM, leg press, leg extension, calve extension). Receives: Other: Exercise intervention |
| Walking | Active comparator | 12-week progressive walking program. Receives: Other: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid force production
Subjects perform a test protocol on a sledge apparatus, consisting of explosive isometric voluntary contractions for the leg-extensor muscles of the right leg. The inclination of the sledge is 20° to horizontal. The seat of the sledge is inclined backwards (130°). The knee joint angle is set at 90° and the hip angle at 70°. The point of force application is aligned with the head of the fifth metatarsal. Subjects are instructed to kick as fast and as hard as possible and maintain their maximum force for approximately 3s. The rate of force development (N/s) is defined as the linear slope of the force-time curve and is measured from the onset of movement till 100 ms.
Measured: Change from baseline in rapid force production at 12 weeks
Jumping height in squat jump
Subjects perform a test protocol on a sledge apparatus, consisting of squat jumps (SJ), countermovement jumps (CMJ), and drop jumps (DJ). The inclination of the sledge is 20° to horizontal. The seat of the sledge is inclined backwards (130°). A force platform is built in perpendicular to the jumping direction. A speed sensor is attached to the seat of the sledge, which is used to assess the transition point between braking and push-off phases and to calculate jumping height (in cm).
Measured: Change from baseline in jumping height at 12 weeks
Jumping height in countermovement jump
Subjects perform a test protocol on a sledge apparatus, consisting of squat jumps (SJ), countermovement jumps (CMJ), and drop jumps (DJ). The inclination of the sledge is 20° to horizontal. The seat of the sledge is inclined backwards (130°). A force platform is built in perpendicular to the jumping direction. A speed sensor is attached to the seat of the sledge, which is used to assess the transition point between braking and push-off phases and to calculate jumping height (in cm).
Measured: Change from baseline in jumping height at 12 weeks
Jumping height in drop jump
Subjects perform a test protocol on a sledge apparatus, consisting of squat jumps (SJ), countermovement jumps (CMJ), and drop jumps (DJ). The inclination of the sledge is 20° to horizontal. The seat of the sledge is inclined backwards (130°). A force platform is built in perpendicular to the jumping direction. A speed sensor is attached to the seat of the sledge, which is used to assess the transition point between braking and push-off phases and to calculate jumping height (in cm).
Measured: Change from baseline in jumping height at 12 weeks
Secondary outcomes (8)
Leg press one-repetition maximum
Leg press one-repetition maximum is defined as the maximum weight (in kg) that the subject can push on a leg press device (Signature Series Leg press Life Fitness).
Measured: Change from baseline in leg press 1-RM at 12 weeks
Maximal isometric strength
Maximal strength (Nm) is measured by means of unilateral isometric knee-extensor tests on a Biodex dynamometer.
Measured: Change from baseline in maximal isometric strength at 12 weeks
Maximal isokinetic strength
Maximal strength (Nm) is measured by means of unilateral isokinetic knee-extensor tests on a Biodex dynamometer.
Measured: Change from baseline in maximal isokinetic strength at 12 weeks
Stair Climbing performance
Stair ascent duration (in s), the time needed to ascent a flight of stairs.
Measured: Change from baseline in Stair Climbing performance at 12 weeks
Gait speed
The average speed to walk 10m as fast as possible (in m/s).
Measured: Change from baseline in gait speed at 12 weeks
5 repetition sit-to-stand test
The time needed to perform 5 sit-to-stand transitions (in s).
Measured: Change from baseline in sit-to-stand duration at 12 weeks
6 minute walk distance
The walk distance (in m) covered in 6 min.
Measured: Change from baseline in 6min walk distance at 12 weeks
Balance
Overall balance performance is assessed using the total length of the sway path divided by duration of the measurement (mm/s) in a 30s balance test on a balance board.
Measured: Change from baseline in balance at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start29 Jan 2018
- Primary completion19 Jun 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelien Van Roie, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645772
- Sponsor's protocol ID
- S60983
- Status last verified
- Aug 2018
- First submitted
- 17 Aug 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plyometric Exercise to Improve Rapid Force Production in Older Men: a Pilot Intervention
- ClinicalTrials.gov ID
- NCT03645772
- Acronym / sponsor ID
- S60983
- Conditions
- Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rapid force production declines as a consequence of ageing. Given the functional relevance of rapid force production, exercise interventions in older adults should aim at improving the capacity to produce force rapidly. To improve this capacity, exercises should be performed with the intention to develop high speeds, as supported by previous work.
Human locomotion fundamentally consists of multi-joint movements and rapidly coupled eccentric-concentric muscle actions, known as stretch-shortening cycle (SSC) activities or plyometrics. Plyometrics might therefore be used to optimize power production. However, there is limited research on the feasibility of plyometrics in older adults and its potential effects on rapid force production and functional capacity. This study will test the feasibility of a 12-week plyometric exercise intervention in older men and compare its effects on rapid force production to a traditional resistance exercise or walking intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Plyometric exercise | Experimental | Other: Exercise intervention12-week progressive exercise program, consisting of plyometric exercises such as countermovement jump, forward and sideways step-up. |
| Resistance exercise | Active comparator | Other: Exercise intervention12-week resistance exercise program for the leg muscles (2-4 sets of 8-15 repetitions at 8-15RM, leg press, leg extension, calve extension). |
| Walking | Active comparator | Other: Exercise intervention12-week progressive walking program. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (5 listed)
- No systematic engagement in (resistance) exercise in the 12-months prior to participation
- Cardiovascular disease
- Neurological disorders
- Cognitive malfunctioning
- Severe knee or hip problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise intervention12-week progressive training intervention | Other | Plyometric exercise, Resistance exercise, Walking |
Primary outcome
Rapid force production
Time frame: Change from baseline in rapid force production at 12 weeks
Subjects perform a test protocol on a sledge apparatus, consisting of explosive isometric voluntary contractions for the leg-extensor muscles of the right leg. The inclination of the sledge is 20° to horizontal. The seat of the sledge is inclined backwards (130°). The knee joint angle is set at 90° and the hip angle at 70°. The point of force application is aligned with the head of the fifth metatarsal. Subjects are instructed to kick as fast and as hard as possible and maintain their maximum force for approximately 3s. The rate of force development (N/s) is defined as the linear slope of the force-time curve and is measured from the onset of movement till 100 ms.
Jumping height in squat jump
Time frame: Change from baseline in jumping height at 12 weeks
Subjects perform a test protocol on a sledge apparatus, consisting of squat jumps (SJ), countermovement jumps (CMJ), and drop jumps (DJ). The inclination of the sledge is 20° to horizontal. The seat of the sledge is inclined backwards (130°). A force platform is built in perpendicular to the jumping direction. A speed sensor is attached to the seat of the sledge, which is used to assess the transition point between braking and push-off phases and to calculate jumping height (in cm).
Jumping height in countermovement jump
Time frame: Change from baseline in jumping height at 12 weeks
Subjects perform a test protocol on a sledge apparatus, consisting of squat jumps (SJ), countermovement jumps (CMJ), and drop jumps (DJ). The inclination of the sledge is 20° to horizontal. The seat of the sledge is inclined backwards (130°). A force platform is built in perpendicular to the jumping direction. A speed sensor is attached to the seat of the sledge, which is used to assess the transition point between braking and push-off phases and to calculate jumping height (in cm).
Jumping height in drop jump
Time frame: Change from baseline in jumping height at 12 weeks
Subjects perform a test protocol on a sledge apparatus, consisting of squat jumps (SJ), countermovement jumps (CMJ), and drop jumps (DJ). The inclination of the sledge is 20° to horizontal. The seat of the sledge is inclined backwards (130°). A force platform is built in perpendicular to the jumping direction. A speed sensor is attached to the seat of the sledge, which is used to assess the transition point between braking and push-off phases and to calculate jumping height (in cm).
8 secondary outcomes
Leg press one-repetition maximum
Time frame: Change from baseline in leg press 1-RM at 12 weeks
Maximal isometric strength
Time frame: Change from baseline in maximal isometric strength at 12 weeks
Maximal isokinetic strength
Time frame: Change from baseline in maximal isokinetic strength at 12 weeks
Stair Climbing performance
Time frame: Change from baseline in Stair Climbing performance at 12 weeks
Gait speed
Time frame: Change from baseline in gait speed at 12 weeks
5 repetition sit-to-stand test
Time frame: Change from baseline in sit-to-stand duration at 12 weeks
6 minute walk distance
Time frame: Change from baseline in 6min walk distance at 12 weeks
Balance
Time frame: Change from baseline in balance at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Exercise Training, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid force production (time frame: Change from baseline in rapid force production at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.