Quality of LifeNCT06107855
Low-dose Maximal-intent Versus Controlled-tempo Resistance Training on Quality-of-life in Adults
A study testing Leg Press Resistance Training Machine in people with Quality of Life, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The aims of this study were to: 1. Compare the effects of low-dose Maximal Intent and Controlled Tempo Resistance Training on untrained healthy adults' quality-of-life, functional capacity, and strength. 2. Qualitatively explore perceptions of Maximal Intent and Controlled Tempo Resistance Training. Read more about this study
- Who is it for?
- Ages 30 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Leg Press Resistance Training Machine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2022to 29 Mar 2023
- 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 30 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants were eligible if they were between 30-60 years old
- Uninjured
- Had no cardiovascular or neuromuscular conditions
- Had not participated in lower-limb RT in the previous six months.
Who cannot join
- Participants were excluded if they had either taken part in any lower-limb RT in the last six months
- Had underlying health condition(s) that prevented them from participating in RT
- Regularly met or exceeded the UK recommended PA guideline of 150-minutes of moderate to intense PA per week.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nortuhmbria University
Newcastle, Tyne and Wear, NE1 8ST
About this study
Official title: Comparison of Low-dose Maximal-intent Versus Controlled-tempo Resistance Training on Quality-of-life, Functional Capacity, and Strength in Untrained Healthy Adults: a Randomised Controlled Trial
The aims of this study were to:
- Compare the effects of low-dose Maximal Intent and Controlled Tempo Resistance Training on untrained healthy adults' quality-of-life, functional capacity, and strength.
- Qualitatively explore perceptions of Maximal Intent and Controlled Tempo Resistance Training.
- Conditions
- Quality of Life
- Being tested
- Leg Press Resistance Training Machine
- Keywords
- Activities of Daily Living, Balance, Independence, Mobility, Untrained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg Press Resistance Training MachineOther
Participants used said unilateral leg press at 60% one-repetition max for either 3 sets x 5 reps, or 5 sets x 5 reps, at either maximal- or controlled-tempo-intent.
| Study group | Role | What they receive |
|---|---|---|
| Maximal-intent Resistance Training | Experimental | The MI group was instructed and encouraged to deliberately commit to exerting maximal effort and force during the concentric phase of the leg press with the intention of achieving the greatest velocity possible. Receives: Other: Leg Press Resistance Training Machine |
| Controlled-tempo Resistance Training | Experimental | While the CT group followed the metronome for both eccentric and concentric phases. Receives: Other: Leg Press Resistance Training Machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality-of-life
Participant quality of life (focus group questions \& SF-36)
Measured: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
Secondary outcomes (7)
Balance
Using the biodex SD to do a 3 x 20s double-foot eyes-open balance test on Level 6.
Measured: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
6-minute Walk Test (6MWT)
a "brisk"-paced 6-minute walk test.
Measured: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
Timed-up-and-go (TUG)
Standing from a chair, walking to a point 3 metres away, turn, and return to the chair as quick as possible whilst walking.
Measured: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
30-second sit-to-stand (30s-STS)
Maximal amount of repetitions a participant can stand up from a chair in 30-seconds.
Measured: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
Strength (1RM)
Participants one-repetition max on leg press
Measured: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
BMI
Additional measures calculated from participants test results
Measured: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
Strength-to-mass
Additional measures calculated from participants test results
Measured: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Aug 2022
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gill Barry, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107855
- Sponsor's protocol ID
- 45459
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pearson LT, Behm DG, Goodall S, Mason R, Stuart S, Barry G. Effects of maximal-versus submaximal-intent resistance training on functional capacity and strength in community-dwelling older adults: a systematic review and meta-analysis. BMC Sports Sci Med Rehabil. 2022 Jul 16;14(1):129. doi: 10.1186/s13102-022-00526-x.
PubMed 35842655Pearson LT, Fox KT, Keenan A, Behm DG, Stuart S, Goodall S, Barry G. Comparison of low-dose maximal-intent versus controlled-tempo resistance training on quality-of-life, functional capacity, and strength in untrained healthy adults: a comparative effectiveness study. BMC Sports Sci Med Rehabil. 2024 Mar 23;16(1):72. doi: 10.1186/s13102-024-00847-z.
PubMed 38521946
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low-dose Maximal-intent Versus Controlled-tempo Resistance Training on Quality-of-life, Functional Capacity, and Strength in Untrained Healthy Adults: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06107855
- Acronym / sponsor ID
- 45459
- Conditions
- Quality of Life
- Keywords
- Activities of Daily Living, Balance, Independence, Mobility, Untrained
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 30 Oct 2023 (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.
The aims of this study were to:
- Compare the effects of low-dose Maximal Intent and Controlled Tempo Resistance Training on untrained healthy adults' quality-of-life, functional capacity, and strength.
- Qualitatively explore perceptions of Maximal Intent and Controlled Tempo Resistance Training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximal-intent Resistance Training | Experimental | Other: Leg Press Resistance Training MachineThe MI group was instructed and encouraged to deliberately commit to exerting maximal effort and force during the concentric phase of the leg press with the intention of achieving the greatest velocity possible. |
| Controlled-tempo Resistance Training | Experimental | Other: Leg Press Resistance Training MachineWhile the CT group followed the metronome for both eccentric and concentric phases. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants were eligible if they were between 30-60 years old
- Uninjured
- Had no cardiovascular or neuromuscular conditions
- Had not participated in lower-limb RT in the previous six months.
Key exclusion criteria (3 listed)
- Participants were excluded if they had either taken part in any lower-limb RT in the last six months
- Had underlying health condition(s) that prevented them from participating in RT
- Regularly met or exceeded the UK recommended PA guideline of 150-minutes of moderate to intense PA per week.
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 |
|---|---|---|
| Leg Press Resistance Training MachineParticipants used said unilateral leg press at 60% one-repetition max for either 3 sets x 5 reps, or 5 sets x 5 reps, at either maximal- or controlled-tempo-intent. | Other | Controlled-tempo Resistance Training, Maximal-intent Resistance Training |
Primary outcome
Quality-of-life
Time frame: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
Participant quality of life (focus group questions \& SF-36)
7 secondary outcomes
Balance
Time frame: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
6-minute Walk Test (6MWT)
Time frame: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
Timed-up-and-go (TUG)
Time frame: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
30-second sit-to-stand (30s-STS)
Time frame: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
Strength (1RM)
Time frame: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
BMI
Time frame: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.
Strength-to-mass
Time frame: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 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 30 Oct 2023.
- Background: PubMed 35842655Pearson LT, Behm DG, Goodall S, Mason R, Stuart S, Barry G. Effects of maximal-versus submaximal-intent resistance training on functional capacity and strength in community-dwelling older adults: a systematic review and meta-analysis. BMC Sports Sci Med Rehabil. 2022 Jul 16;14(1):129. doi: 10.1186/s13102-022-00526-x.
- Derived from this study: PubMed 38521946Pearson LT, Fox KT, Keenan A, Behm DG, Stuart S, Goodall S, Barry G. Comparison of low-dose maximal-intent versus controlled-tempo resistance training on quality-of-life, functional capacity, and strength in untrained healthy adults: a comparative effectiveness study. BMC Sports Sci Med Rehabil. 2024 Mar 23;16(1):72. doi: 10.1186/s13102-024-00847-z.
- 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.
Gill Barry, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg Press Resistance Training Machine in people with Quality of Life, run by Northumbria University at 1 site in United Kingdom.
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 4 inclusion and 3 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 30 Oct 2023. 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 United Kingdom. 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?
Quality-of-life (time frame: The time frame for my testing intervals will be conducted at specific time points: at baseline, Week 1, Week 4, and Week 9, out of a total study duration of 9 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06107855, which also lists 2 linked publications.
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 30 Oct 2023.