Quality of LifeST-QOLNCT03952104
Strength Training and Quality of Life in Elderly
A study testing Strength training in people with Quality of Life, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Aim: To evaluate the impact of three different strength training programs on psychological wellbeing of elderly. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 22 May 2019to 10 Jul 2020
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥60 years;
- having the ability to speak and write in Spanish;
- having the ability to complete the questionnaires independently.
Who cannot join
- -the presence of any medical problem or pathology that could hinder physical activity practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Strength Training Programs on Quality of Life in Elderly
Aim: To evaluate the impact of three different strength training programs on psychological wellbeing of elderly.
Read the detailed description
Background: Physical activity in the elderly has benefits which improve psychological wellbeing. However, the majority of older adults perform less physical activity with advancing age.
Aim: To evaluate the impact of three different 32-week strength training programs (low, moderate and high intensity) on psychological wellbeing of elderly.
Design: Randomized Controlled Trial.
- Conditions
- Quality of Life
- Being tested
- Strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
Strength training
| Study group | Role | What they receive |
|---|---|---|
| Experimental-Low Intensity Strength Training | Experimental | Strength training (low intensity) Receives: Other: Strength training |
| Experimental-Moderate Intensity Strength Training | Experimental | Strength training (moderate intensity) Receives: Other: Strength training |
| Experimental-High Intensity Strength Training | Experimental | Strength training (high intensity) Receives: Other: Strength training |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life, assessed through the Short Form 36 health survey questionnaire.
This questionnaire measures quality of live. It provides information on 8 scales, scoring from 0 (worst health) to 100 (best health), and on the physical component scale (PCS) and the mental component scale (MCS), normalized scores representing overall physical and mental functioning.
Measured: 32 weeks
Secondary outcomes (2)
Emotional wellbeing, assessed through the STAI (State-Trait Anxiety Inventory) questionnaire.
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983). It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress. STAI has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: 32 weeks
Motivation towards physical activity, assessed through the Behavioural Regulation in Exercise Questionnaire (BREQ-2)
This questionnaire consists of 19 items measuring stages on the continuum of self-determination. It measures external regulation (4 items), introjected regulation (3 items), identified regulation (4 items), intrinsic regulation (4 items), and it adds amotivation (4 items) on a scale from 1 (Not at all true for me) to 5 (Absolutely true for me). Each of the subscales has a maximum score, with a maximum of 20 for external regulation, identified regulation, intrinsic regulation and amotivation, and 15 for introjected regulation.
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start22 May 2019
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Lisón Párraga, Dr, Cardenal Herrera University
- Investigators
- JF Lisón, PhD, Study director, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952104
- Sponsor's protocol ID
- UNIVERSITY CARDENAL HERRERA-19
- Acronym
- ST-QOL
- Status last verified
- Jul 2020
- First submitted
- 13 May 2019
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Strength Training Programs on Quality of Life in Elderly
- ClinicalTrials.gov ID
- NCT03952104
- Acronym / sponsor ID
- ST-QOL / UNIVERSITY CARDENAL HERRERA-19
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 16 May 2019 (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.
Aim: To evaluate the impact of three different strength training programs on psychological wellbeing of elderly.
Detailed description
Background: Physical activity in the elderly has benefits which improve psychological wellbeing. However, the majority of older adults perform less physical activity with advancing age.
Aim: To evaluate the impact of three different 32-week strength training programs (low, moderate and high intensity) on psychological wellbeing of elderly.
Design: Randomized Controlled Trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental-Low Intensity Strength Training | Experimental | Other: Strength trainingStrength training (low intensity) |
| Experimental-Moderate Intensity Strength Training | Experimental | Other: Strength trainingStrength training (moderate intensity) |
| Experimental-High Intensity Strength Training | Experimental | Other: Strength trainingStrength training (high intensity) |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥60 years;
- having the ability to speak and write in Spanish;
- having the ability to complete the questionnaires independently.
Key exclusion criteria (1 listed)
- -the presence of any medical problem or pathology that could hinder physical activity practice
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 |
|---|---|---|
| Strength trainingStrength training | Other | Experimental-High Intensity Strength Training, Experimental-Low Intensity Strength Training, Experimental-Moderate Intensity Strength Training |
Primary outcome
Quality of life, assessed through the Short Form 36 health survey questionnaire.
Time frame: 32 weeks
This questionnaire measures quality of live. It provides information on 8 scales, scoring from 0 (worst health) to 100 (best health), and on the physical component scale (PCS) and the mental component scale (MCS), normalized scores representing overall physical and mental functioning.
2 secondary outcomes
Emotional wellbeing, assessed through the STAI (State-Trait Anxiety Inventory) questionnaire.
Time frame: 32 weeks
Motivation towards physical activity, assessed through the Behavioural Regulation in Exercise Questionnaire (BREQ-2)
Time frame: 32 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 16 Jul 2020.
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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.
JF Lisón, PhD study director
Cardenal Herrera 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 Strength training in people with Quality of Life, run by Cardenal Herrera University at 1 site in Spain.
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 3 inclusion and 1 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 16 Jul 2020. 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 Spain. 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, assessed through the Short Form 36 health survey questionnaire. (time frame: 32 weeks). 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 16 Jul 2020.