AgingNCT03723902
The Effect of Strength Training and Protein Supplementation in Old Pre-frail Individuals
A study testing Heavy-load strength training and Protein supplementation in people with Aging, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
The aim of this study is to investigate the effects of a lower-body strength training regime combined with protein supplementation in pre-frail elderly individuals. Participants are randomized to a group performing three weekly sessions of heavy-load strength training for 10 weeks and receiving daily protein… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Heavy-load strength training and Protein supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jul 2015to 21 Dec 2015
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age > 75
- Short Physical Performance Battery (SPPB) score ≤ 10
Who cannot join
- Lactose intolerance
- Milk allergy
- Diseases or musculoskeletal disorders contraindicating training/testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strength Training and Protein Supplementation in Pre-frail Elderly Individuals. Effects on Muscle Mass, Muscle Strength, Rate of Force Development and Functional Capacity
The aim of this study is to investigate the effects of a lower-body strength training regime combined with protein supplementation in pre-frail elderly individuals. Participants are randomized to a group performing three weekly sessions of heavy-load strength training for 10 weeks and receiving daily protein supplementation, or a non-training, non-supplemented control group. The endpoints are changes in body composition, the relative changes in different compartments of the quadriceps femoris muscles, and the relationships between changes in muscle mass, muscle thickness, strength, and functional capacity. The investigators hypothesize that 10 weeks of heavy load strength training and protein supplementation will elicit improvements in muscle mass, strength, and functional performance. Moreover, it is hypothesized that improvements in strength will correlate with the improvements in functional performance.
Read the detailed description
Aging is accompanied by a loss of muscle mass and strength. Because muscle strength is associated with functional performance in elderly individuals, various tasks of daily living is hampered by the overall decline. The consequence is a vicious circle, where inactivity caused by reduced functional capacity accelerates the loss of muscle mass, strength and physical function. The Short Physical Performance Battery (SPPB) is commonly used to assess functional capacity, where individuals with a score of 10 or less out of maximum 12 may be categorized as pre-frail. Because small-to-moderate limitations in functional status assessed by SPPB is associated with higher odds of losing future mobility, these individuals represent a group of great interest. Strategies to improve functional capacity in this population are therefore important. It is established that heavy-load strength training, alone or in combination with protein supplementation, can improve muscle mass, strength, and function in elderly individuals. However, most studies have focused on healthy older adults, and less is known about the effects of heavy-load strength training in pre-frail elderly individuals. Moreover, the extent to which training-induced gains in muscle mass and size are related to improvements in strength and functional capacity is still poorly understood, because few intervention studies in this population have quantified hypertrophy precisely. Hence, the aim of this study is to investigate the effects of 10 weeks of heavy load strength training, performed three times per week, on muscle mass (DXA scan), muscle thickness (ultrasound), muscle strength (dynamic and isometric), rate of force development, chair rise ability, and gait velocity. Participants are randomized to a group performing three weekly sessions of heavy-load strength training or a control group. In addition, to optimize gains in muscle mass and strength, the strength training group will receive daily protein supplementation throughout the intervention period. The investigators hypothesize that the intervention will improve muscle mass, muscle thickness and strength, and that improvements in muscle strength and rate of force development will be correlated with improvements in functional capacity.
- Conditions
- Aging
- Being tested
- Heavy-load strength training, Protein supplementation
- Keywords
- Strength training, Pre-frail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy-load strength trainingOther
Also called Resistance exercise
Three weekly sessions of heavy-load strength training for 10 weeks
Protein supplementationDietary supplement
Daily supplementation of 2 x 17 grams of milk protein
| Study group | Role | What they receive |
|---|---|---|
| Strength training + protein supplement | Experimental | Heavy-load strength training, Protein supplementation Receives: Other: Heavy-load strength training; Dietary Supplement: Protein supplementation |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength of m. Quadriceps Femoris
Maximal isometric muscle strength of m. quadriceps femoris (maximal voluntary contraction for the knee extensors)
Measured: Change from baseline at 10 weks
Muscle strength of m. quadriceps femoris
Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum)
Measured: Change from baseline at 10 weeks
Leg lean mass
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Measured: Change from baseline at 10 weeks
Secondary outcomes (13)
Total lean mass
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Measured: Change from baseline at 10 weeks
Fat mass
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Measured: Change from baseline at 10 weeks
Bone mineral density
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Measured: Change from baseline at 10 weeks
m. Vastus Lateralis thickness
Measured by ultrasound
Measured: Change from baseline at 10 weeks
m. Rectus Femoris thickness
Measured by ultrasound
Measured: Change from baseline at 10 weeks
m. Vastus Intermedius thickness
Measured by ultrasound
Measured: Change from baseline at 10 weeks
m. Vastus Medialis thickness
Measured by ultrasound
Measured: Change from baseline at 10 weeks
Isometric knee extension rate of force development (RFD max)
Measured during maximal voluntary contraction
Measured: Change from baseline at 10 weeks
Isometric knee extension force at 100 ms
Force at 100 ms during maximal voluntary contraction
Measured: Change from baseline at 10 weeks
Habitual gait velocity
Time (sec) to walk 6 meters at preferred gait speed
Measured: Change from baseline at 10 weeks
Five times chair-rise performance
Time (sec) to rise from a chair five times
Measured: Change from baseline at 10 weeks
Stair climbing
Time (sec) to climb a staircase
Measured: Change from baseline at 10 weeks
Diet assessment
24-hour diet recall interviews
Measured: Change from baseline at 10 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 2018
- Study start1 Jul 2015
- Primary completion21 Dec 2015
- Study completion21 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Truls Raastad, Norwegian School of Sport Sciences
- Investigators
- Truls Raastad, Prof., Principal investigator, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723902
- Sponsor's protocol ID
- ST-PF
- Status last verified
- Mar 2019
- First submitted
- 26 Oct 2018
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training and Protein Supplementation in Pre-frail Elderly Individuals. Effects on Muscle Mass, Muscle Strength, Rate of Force Development and Functional Capacity
- ClinicalTrials.gov ID
- NCT03723902
- Acronym / sponsor ID
- ST-PF
- Conditions
- Aging
- Keywords
- Strength training, Pre-frail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 21 Dec 2015 (actual)
- Study completion
- 21 Dec 2015 (actual)
- First posted
- 30 Oct 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.
The aim of this study is to investigate the effects of a lower-body strength training regime combined with protein supplementation in pre-frail elderly individuals. Participants are randomized to a group performing three weekly sessions of heavy-load strength training for 10 weeks and receiving daily protein supplementation, or a non-training, non-supplemented control group. The endpoints are changes in body composition, the relative changes in different compartments of the quadriceps femoris muscles, and the relationships between changes in muscle mass, muscle thickness, strength, and functional capacity. The investigators hypothesize that 10 weeks of heavy load strength training and protein supplementation will elicit improvements in muscle mass, strength, and functional performance. Moreover, it is hypothesized that improvements in strength will correlate with the improvements in functional performance.
Detailed description
Aging is accompanied by a loss of muscle mass and strength. Because muscle strength is associated with functional performance in elderly individuals, various tasks of daily living is hampered by the overall decline. The consequence is a vicious circle, where inactivity caused by reduced functional capacity accelerates the loss of muscle mass, strength and physical function. The Short Physical Performance Battery (SPPB) is commonly used to assess functional capacity, where individuals with a score of 10 or less out of maximum 12 may be categorized as pre-frail. Because small-to-moderate limitations in functional status assessed by SPPB is associated with higher odds of losing future mobility, these individuals represent a group of great interest. Strategies to improve functional capacity in this population are therefore important. It is established that heavy-load strength training, alone or in combination with protein supplementation, can improve muscle mass, strength, and function in elderly individuals. However, most studies have focused on healthy older adults, and less is known about the effects of heavy-load strength training in pre-frail elderly individuals. Moreover, the extent to which training-induced gains in muscle mass and size are related to improvements in strength and functional capacity is still poorly understood, because few intervention studies in this population have quantified hypertrophy precisely. Hence, the aim of this study is to investigate the effects of 10 weeks of heavy load strength training, performed three times per week, on muscle mass (DXA scan), muscle thickness (ultrasound), muscle strength (dynamic and isometric), rate of force development, chair rise ability, and gait velocity. Participants are randomized to a group performing three weekly sessions of heavy-load strength training or a control group. In addition, to optimize gains in muscle mass and strength, the strength training group will receive daily protein supplementation throughout the intervention period. The investigators hypothesize that the intervention will improve muscle mass, muscle thickness and strength, and that improvements in muscle strength and rate of force development will be correlated with improvements in functional capacity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength training + protein supplement | Experimental | Other: Heavy-load strength training, Dietary Supplement: Protein supplementationHeavy-load strength training, Protein supplementation |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age > 75
- Short Physical Performance Battery (SPPB) score ≤ 10
Key exclusion criteria (3 listed)
- Lactose intolerance
- Milk allergy
- Diseases or musculoskeletal disorders contraindicating training/testing
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 |
|---|---|---|
| Heavy-load strength trainingAlso: Resistance exerciseThree weekly sessions of heavy-load strength training for 10 weeks | Other | Strength training + protein supplement |
| Protein supplementationDaily supplementation of 2 x 17 grams of milk protein | Dietary supplement | Strength training + protein supplement |
Primary outcome
Muscle strength of m. Quadriceps Femoris
Time frame: Change from baseline at 10 weks
Maximal isometric muscle strength of m. quadriceps femoris (maximal voluntary contraction for the knee extensors)
Muscle strength of m. quadriceps femoris
Time frame: Change from baseline at 10 weeks
Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum)
Leg lean mass
Time frame: Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
13 secondary outcomes
Total lean mass
Time frame: Change from baseline at 10 weeks
Fat mass
Time frame: Change from baseline at 10 weeks
Bone mineral density
Time frame: Change from baseline at 10 weeks
m. Vastus Lateralis thickness
Time frame: Change from baseline at 10 weeks
m. Rectus Femoris thickness
Time frame: Change from baseline at 10 weeks
m. Vastus Intermedius thickness
Time frame: Change from baseline at 10 weeks
m. Vastus Medialis thickness
Time frame: Change from baseline at 10 weeks
Isometric knee extension rate of force development (RFD max)
Time frame: Change from baseline at 10 weeks
Isometric knee extension force at 100 ms
Time frame: Change from baseline at 10 weeks
Habitual gait velocity
Time frame: Change from baseline at 10 weeks
Five times chair-rise performance
Time frame: Change from baseline at 10 weeks
Stair climbing
Time frame: Change from baseline at 10 weeks
Diet assessment
Time frame: Change from baseline at 10 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 14 Mar 2019.
- 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.
Truls Raastad, Prof. principal investigator
Norwegian School of Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy-load strength training and Protein supplementation in people with Aging, run by Norwegian School of Sport Sciences at 1 site in Norway.
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 2 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 14 Mar 2019. 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 Norway. 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?
Muscle strength of m. Quadriceps Femoris (time frame: Change from baseline at 10 weks). The study lists 3 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 14 Mar 2019.