SarcopeniaSPAFNCT06496204
Swedish Physical Activity and Fitness Longitudinal Study
An observational study of Sarcopenia and Physical Fitness, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Aging means loss of strength, which can affect the ability to lead an active life and be independent. Physical activity can counteract the loss of strength to some extent, but individual differences are large and the mechanisms are partly unknown. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Physical Fitness, Muscle Strength
- How many people
- 429 participants
- Where
- 1 siteSweden
- Study dates
- 22 Mar 2021to 8 Jun 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: se above
Who may be able to join
- Belonging to the 0.5% of all pupils who entered secondary high school in Sweden in 1974 and attended one of the systematically selected secondary high schools, and was belonging to the systematically selected pupils.
Who cannot join
- not being part of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal Approach to Characterize Loss of Muscle Mass and Function in Ageing Humans
Aging means loss of strength, which can affect the ability to lead an active life and be independent. Physical activity can counteract the loss of strength to some extent, but individual differences are large and the mechanisms are partly unknown. The hypothesis is that changes in the innervation and composition of the muscle may explain the individual differences in strength loss. A group of Swedish men and women have participated in this study of physical performance for almost 50 years, since they were 16 years old. The project will improve the understanding of muscle aging. The findings may help to develop strategies to counteract muscle loss and enable healthy aging and to promote physical activity throughout life
Read the detailed description
STUDY MATERIALS: The investigators have finished the latest data collection performed at age 63 in 2021-2022 of the human longitudinal cohort study SPAF-1958. At baseline, in 1974, six geographic areas in Sweden were systematically selected. In each area, one upper secondary school was randomly selected, from which 429 (224 male, and 205 female) pupils in the lowest grade level were randomly selected to be included in the study. The entire cohort was invited for questionnaire and testing at age 16, 34 and 52 and 63 years. DATA COLLECTION: Questionnaire: The questionnaire included questions about lifestyle factors such as physical activity, dietary habits, smoking, alcohol consumption.
The questionnaire also included questions about health, disease, medication, and personal traits. Testing of physical performance: Some tests for physical performance were used at all data collections from 16 to 63 years, including aerobic capacity and muscle static and dynamic strength. Specific tests assessing muscle function in relation to muscle weakness were added to the testing at 63 years. Venous blood was drawn for analysis of standard health variables as well as extended studying of endocrine profile and inflammatory cell profile. The muscle size of two selected muscles on the leg were estimated by ultrasound. Body composition and muscle size were determined in 60 subjects by MR imaging of the whole body. Testing of neurological status: Motor nerve conductions studies (NCS) were performed on the right median and ulnar, and bilaterally on tibial, and peroneal nerves. Sensory NCS were performed on the right median, ulnar, and superficial radial nerves, and bilaterally on the sural and superficial peroneal nerves. Motor and sensory conduction velocities, proximal and distal compound muscle action potentials (CMAP), and sensory nerve action potentials (SNAP) were recorded. For motor unit number estimation (MUNE) m. tibialis anterior (TA) and m. abductor policies brevis (ABP) were tested by electrical stimulation of the median and peroneal nerve, respectively. MUNE was obtained by dividing the size of the maximal CMAP by the size of the mean surface-recorded single motor unit potential (S-MUP). MUNE=Max CMAP (area) / Mean SMUP (area). To define small fibre neuropathy a skin biopsy was collected to measure the density of small fibre epidermal innervation. Skeletal muscle samples were obtained with a Bergström biopsy needle from m. vastus lateralis and were snap-frozen in liquid nitrogen cooled isopentane and stored at -80°C. To maximize the possibility to include high number of neuromuscular transmission junctions (endplates) in the muscle biopsy, the optimal biopsy site was determined by location of maximal twitch response to electrical nerve stimulation. Furthermore, the needle was re-directed after penetration of the skin to cut myofibers as longitudinally as possible. This approach was chosen to optimize the conditions for analyses of the NMJ.
ANALYSES OF SKELETAL MUSCLE: The data collection at 63 years will be completed with morphological and immune-/enzyme-histochemical analysis of 120 muscle biopsies. Disruption of axon and motor unit integrity may initiate and drive the wasting and functional impairment of skeletal muscles during aging. To test our hypothesis of the neurogenic impact on loss of muscle strength, the investigators will examine and compare biopsies of skeletal muscle from age 27 and 63 in the same individuals. This part of the analyses will focus on fibre type transitions (myosin subtypes), change in fibre-size and clustering of fibre types with advancing age (a sign of denervation followed by re-innervation). For the biopsies at age 63, after cryo-sectioning, muscle sections will be stained using enzyme histochemistry, histological stains, and immunohistochemistry, followed by confocal microscopy imaging. From 27 years of age there are sectioned and stained muscle tissue available from a subgroup of the cohort, to compare with the characteristics of the muscle at 63 years. These samples need to be digitalised in our microscopy and imaging analysis facility before analyses of fibre clustering. Also, the muscle biopsies harvested at age 63 will be analysed for NMJ by staining for acetylcholine (presynaptic), CHARNs (postsynaptic receptors), terminal Schwann cells, and the parallel autonomic innervation (norepinephrine). The investigators will use a panel of antibodies including markers of axonal and terminal Schwann cell involvement in re-innervation. The cryo-sectioning and refinement/validation of the labelling protocols will be performed by HR in collaboration with BU, TG and MW. HR has a full-time position in the group and is specialized in these methods. In addition, the investigators apply for funding 1 month for a research assistant to digitalise and analyse muscle fibre composition from age 27. ANALYSES OF MAGNETIC RESONANCE IMAGES Subjects have been scanned with a 1.5 Tesla Siemens camera at Karolinska University Hospital in Huddinge. The investigators used a modified 2-point Dixon fat-water sequence that scans the entire body in 6 minutes. Automatic image analysis will be performed using AMRA™ segmentation software (Advanced MR Analytics AB, Linköping, Sweden). The data provided include adipose and muscle tissue of the entire body (from neck to knee), muscle volume and muscle fat infiltration in the anterior and posterior thigh muscles, and subcutaneous adipose tissue in the abdomen and fat content of the liver. The advantage of the results of the MRI technique is not only the very high reproducibility, but also the fact that it can be adjusted to body size using muscle-specific z-scores for volume and fat infiltration. This has been a major problem in the past, as essentially small people were much more easily classified as sarcopenic, while overweight/obese people were rarely classified as having too little muscle mass. The standardized z-score has been calculated for different age groups based on over 10 000 people scanned in the UK Biobank. Both muscle volume value and fat infiltration of muscle were associated with physical function, with the strongest predictive value when low muscle volume was combined with high fat infiltration, i.e. adverse muscle composition.
- Conditions
- Sarcopenia, Physical Fitness, Muscle Strength, Dynapenia, Aerobic Fitness
- Keywords
- physical fitness, aerobic capacity, skeletal muscle, neuromuscular junction, motor unit, ageing, longitudinal study, immunohistochemistry, UPS system
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SPAF | At the beginning of the study, in 1974, a group of 429 (224 males, and 205 females) of pupils at secondary high school in Sweden was systematically selected: The country was stratified into six regions with a similar population size and climate. In each region, one or more secondary high schools were randomly selected. At each school, the number of pupils was selected in proportion to the distribution of girls and boys in secondary high school, the number of pupils in the region, and the proportion of pupils in each school program (theoretical three-year program to prepare for higher studies or practical two-year program to prepare for working life). Individual subjects were then randomly selected at each school based on these criteria and are representative of 16-year-old girls and boys attending secondary high school in Sweden. All participants have been invited to followups at age 34, 52 and 63 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity
Submaximal ergometer test estimating maximal oxygen consumption (L/min)
Measured: through study completion, an average of 70 year
Skeletal muscle fiber distribution
Proportion of type I and type II skeletal muscle fibers from biopsies
Measured: through study completion, an average of 70 year
Sargent Jump
Vertical jump (cm)
Measured: through study completion, an average of 70 year
Muscular endurance
Bench press test with women lifting 12 kg and med 20 kg at a pace of 25 lifts per minute until exhaustion
Measured: through study completion, an average of 70 year
Secondary outcomes (2)
physical activity
Questionnaire: "Are you leisure-time physically active" (yes or no)
Measured: through study completion, an average of 70 year
Educational level
Questionnaire: Do you have a university education? Yes or no. Self reported
Measured: through study completion, an average of 70 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start22 Mar 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Research Council for Sport Science, The Swedish Research Council
- Responsible party
- Principal investigator, Maria Westerstahl, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496204
- Sponsor's protocol ID
- SPAF: dnr 2020-04338 SERA
- Other IDs
- DNR 4-397/2021, DNR 4-2537/2023, P2023-0054, P2024-0076
- Acronym
- SPAF
- Status last verified
- Mar 2025
- First submitted
- 27 May 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publication data can be shared
Publications
Westerstahl M, Jornaker G, Jansson E, Aasa U, Ingre M, Pourhamidi K, Ulfhake B, Gustafsson T. Rise and Fall of Physical Capacity in a General Population: A 47-Year Longitudinal Study. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70134. doi: 10.1002/jcsm.70134.
PubMed 41243424
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Approach to Characterize Loss of Muscle Mass and Function in Ageing Humans
- ClinicalTrials.gov ID
- NCT06496204
- Acronym / sponsor ID
- SPAF / SPAF: dnr 2020-04338 SERA
- Conditions
- Sarcopenia, Physical Fitness, Muscle Strength, Dynapenia, Aerobic Fitness
- Keywords
- physical fitness, aerobic capacity, skeletal muscle, neuromuscular junction, motor unit, ageing, longitudinal study, immunohistochemistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Research Council for Sport Science, The Swedish Research Council
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 11 Jul 2024 (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.
Aging means loss of strength, which can affect the ability to lead an active life and be independent. Physical activity can counteract the loss of strength to some extent, but individual differences are large and the mechanisms are partly unknown. The hypothesis is that changes in the innervation and composition of the muscle may explain the individual differences in strength loss. A group of Swedish men and women have participated in this study of physical performance for almost 50 years, since they were 16 years old. The project will improve the understanding of muscle aging. The findings may help to develop strategies to counteract muscle loss and enable healthy aging and to promote physical activity throughout life
Detailed description
STUDY MATERIALS: The investigators have finished the latest data collection performed at age 63 in 2021-2022 of the human longitudinal cohort study SPAF-1958. At baseline, in 1974, six geographic areas in Sweden were systematically selected. In each area, one upper secondary school was randomly selected, from which 429 (224 male, and 205 female) pupils in the lowest grade level were randomly selected to be included in the study. The entire cohort was invited for questionnaire and testing at age 16, 34 and 52 and 63 years. DATA COLLECTION: Questionnaire: The questionnaire included questions about lifestyle factors such as physical activity, dietary habits, smoking, alcohol consumption.
The questionnaire also included questions about health, disease, medication, and personal traits. Testing of physical performance: Some tests for physical performance were used at all data collections from 16 to 63 years, including aerobic capacity and muscle static and dynamic strength. Specific tests assessing muscle function in relation to muscle weakness were added to the testing at 63 years. Venous blood was drawn for analysis of standard health variables as well as extended studying of endocrine profile and inflammatory cell profile. The muscle size of two selected muscles on the leg were estimated by ultrasound. Body composition and muscle size were determined in 60 subjects by MR imaging of the whole body. Testing of neurological status: Motor nerve conductions studies (NCS) were performed on the right median and ulnar, and bilaterally on tibial, and peroneal nerves. Sensory NCS were performed on the right median, ulnar, and superficial radial nerves, and bilaterally on the sural and superficial peroneal nerves. Motor and sensory conduction velocities, proximal and distal compound muscle action potentials (CMAP), and sensory nerve action potentials (SNAP) were recorded. For motor unit number estimation (MUNE) m. tibialis anterior (TA) and m. abductor policies brevis (ABP) were tested by electrical stimulation of the median and peroneal nerve, respectively. MUNE was obtained by dividing the size of the maximal CMAP by the size of the mean surface-recorded single motor unit potential (S-MUP). MUNE=Max CMAP (area) / Mean SMUP (area). To define small fibre neuropathy a skin biopsy was collected to measure the density of small fibre epidermal innervation. Skeletal muscle samples were obtained with a Bergström biopsy needle from m. vastus lateralis and were snap-frozen in liquid nitrogen cooled isopentane and stored at -80°C. To maximize the possibility to include high number of neuromuscular transmission junctions (endplates) in the muscle biopsy, the optimal biopsy site was determined by location of maximal twitch response to electrical nerve stimulation. Furthermore, the needle was re-directed after penetration of the skin to cut myofibers as longitudinally as possible. This approach was chosen to optimize the conditions for analyses of the NMJ.
ANALYSES OF SKELETAL MUSCLE: The data collection at 63 years will be completed with morphological and immune-/enzyme-histochemical analysis of 120 muscle biopsies. Disruption of axon and motor unit integrity may initiate and drive the wasting and functional impairment of skeletal muscles during aging. To test our hypothesis of the neurogenic impact on loss of muscle strength, the investigators will examine and compare biopsies of skeletal muscle from age 27 and 63 in the same individuals. This part of the analyses will focus on fibre type transitions (myosin subtypes), change in fibre-size and clustering of fibre types with advancing age (a sign of denervation followed by re-innervation). For the biopsies at age 63, after cryo-sectioning, muscle sections will be stained using enzyme histochemistry, histological stains, and immunohistochemistry, followed by confocal microscopy imaging. From 27 years of age there are sectioned and stained muscle tissue available from a subgroup of the cohort, to compare with the characteristics of the muscle at 63 years. These samples need to be digitalised in our microscopy and imaging analysis facility before analyses of fibre clustering. Also, the muscle biopsies harvested at age 63 will be analysed for NMJ by staining for acetylcholine (presynaptic), CHARNs (postsynaptic receptors), terminal Schwann cells, and the parallel autonomic innervation (norepinephrine). The investigators will use a panel of antibodies including markers of axonal and terminal Schwann cell involvement in re-innervation. The cryo-sectioning and refinement/validation of the labelling protocols will be performed by HR in collaboration with BU, TG and MW. HR has a full-time position in the group and is specialized in these methods. In addition, the investigators apply for funding 1 month for a research assistant to digitalise and analyse muscle fibre composition from age 27. ANALYSES OF MAGNETIC RESONANCE IMAGES Subjects have been scanned with a 1.5 Tesla Siemens camera at Karolinska University Hospital in Huddinge. The investigators used a modified 2-point Dixon fat-water sequence that scans the entire body in 6 minutes. Automatic image analysis will be performed using AMRA™ segmentation software (Advanced MR Analytics AB, Linköping, Sweden). The data provided include adipose and muscle tissue of the entire body (from neck to knee), muscle volume and muscle fat infiltration in the anterior and posterior thigh muscles, and subcutaneous adipose tissue in the abdomen and fat content of the liver. The advantage of the results of the MRI technique is not only the very high reproducibility, but also the fact that it can be adjusted to body size using muscle-specific z-scores for volume and fat infiltration. This has been a major problem in the past, as essentially small people were much more easily classified as sarcopenic, while overweight/obese people were rarely classified as having too little muscle mass. The standardized z-score has been calculated for different age groups based on over 10 000 people scanned in the UK Biobank. Both muscle volume value and fat infiltration of muscle were associated with physical function, with the strongest predictive value when low muscle volume was combined with high fat infiltration, i.e. adverse muscle composition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPAF | – | –At the beginning of the study, in 1974, a group of 429 (224 males, and 205 females) of pupils at secondary high school in Sweden was systematically selected: The country was stratified into six regions with a similar population size and climate. In each region, one or more secondary high schools were randomly selected. At each school, the number of pupils was selected in proportion to the distribution of girls and boys in secondary high school, the number of pupils in the region, and the proportion of pupils in each school program (theoretical three-year program to prepare for higher studies or practical two-year program to prepare for working life). Individual subjects were then randomly selected at each school based on these criteria and are representative of 16-year-old girls and boys attending secondary high school in Sweden. All participants have been invited to followups at age 34, 52 and 63 years |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- se above
Key inclusion criteria (1 listed)
- Belonging to the 0.5% of all pupils who entered secondary high school in Sweden in 1974 and attended one of the systematically selected secondary high schools, and was belonging to the systematically selected pupils.
Key exclusion criteria (1 listed)
- not being part of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aerobic capacity
Time frame: through study completion, an average of 70 year
Submaximal ergometer test estimating maximal oxygen consumption (L/min)
Skeletal muscle fiber distribution
Time frame: through study completion, an average of 70 year
Proportion of type I and type II skeletal muscle fibers from biopsies
Sargent Jump
Time frame: through study completion, an average of 70 year
Vertical jump (cm)
Muscular endurance
Time frame: through study completion, an average of 70 year
Bench press test with women lifting 12 kg and med 20 kg at a pace of 25 lifts per minute until exhaustion
2 secondary outcomes
physical activity
Time frame: through study completion, an average of 70 year
Educational level
Time frame: through study completion, an average of 70 year
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 13 Aug 2026.
- Results publication: PubMed 41243424Westerstahl M, Jornaker G, Jansson E, Aasa U, Ingre M, Pourhamidi K, Ulfhake B, Gustafsson T. Rise and Fall of Physical Capacity in a General Population: A 47-Year Longitudinal Study. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70134. doi: 10.1002/jcsm.70134.
- Individual participant dataSharing planned: No. Publication data can be shared
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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?
An observational study of Sarcopenia and Physical Fitness, run by Karolinska Institutet at 1 site in Sweden.
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 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 13 Aug 2026. 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 Sweden. 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?
Aerobic capacity (time frame: through study completion, an average of 70 year). 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?
On the ClinicalTrials.gov record for NCT06496204, which also lists 1 linked publication.
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 13 Aug 2026.