SarcopeniaNCT05985616
High Intensity Resistance Training and Possible Sarcopenia
A study testing High Intensity Resistance Training in people with Sarcopenia, run by Riphah International University at 1 site in Pakistan.
Trial summary
Studies conducted so far added the dietary supplements along with resistance training as an intervention, we could not determine whether the observed effects of the intervention were due to the training program and/or dietary supplements. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- High Intensity Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2023to 19 Jan 2024
- 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
- Both male and female
- Age more than 60 years
- Possible sarcopenia cases as defined by Asian Working Group for Sarcopenia (Handgrip strength: Male less than 26kg and Female less than 18kg, 5 time chair stand test more than/equals to 12 seconds)
Who cannot join
- Orthopedic surgery in last one year
- Neurological disorders like stroke etc
- History of recent fractures
- Metabolic disorders like DM etc
- Actively involved in exercise programs
- Cognitive impairment that could confound the assessment
- Wheelchair or bed bound individuals
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Abbas Institute of Medical Sciences
Muzaffarabad, Azad Kashmir
About this study
Official title: Effects of High Intensity Resistance Training on Physical Function in Possible Sarcopenia Cases
Studies conducted so far added the dietary supplements along with resistance training as an intervention, we could not determine whether the observed effects of the intervention were due to the training program and/or dietary supplements.
Read the detailed description
This study will investigate the effects of high intensity resistance training solely in the possible sarcopenia cases which has not done before, to author's knowledge. Furthermore this study will help clinicians to individualize and optimize the therapy for specific patient subgroups, improve the potential of this therapy to improve human function and well being, facilitate timely interventions in community healthcare and prevention settings, which will contribute to higher awareness of sarcopenia prevention and interventions in diverse health care settings.
- Conditions
- Sarcopenia
- Being tested
- High Intensity Resistance Training
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Resistance TrainingOther
High intensity resistance training will be performed 3 times a day for sixteen weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | High intensity (80-85% of 1RM) will be administered at alternative days for 16 weeks.
The exercise will have three phases; Phase I consists of 2-3 sets of 8-15 repetitions, Phase II will follow the single set approach and Phase III will have the Superset approach.
The following activities will be incorporated via resistance training: latissimus front pulleys, rowing, back extension, inverse fly, bench press, shoulder press, lateral raises, butterfly with extended arms, crunches, leg presses, leg extension and curls, leg adduction, abduction. Receives: Other: High Intensity Resistance Training |
| Group B | No intervention | No intervention will be provided in this group. The participants in this group will follow their usual daily activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Dynamometer
it used to measure the hand grip strength. the test-retest reliability is 0.91 and 0.95 with excellent reliability. The assessment will be made at baseline, week 8 and 16
Measured: 16 weeks
Short performance physical battery
an objective assessment tool for evaluating lower extremity functioning in older persons. the test-retest reliability is 0.87. It was used to measure at baseline, week 8 and 16
Measured: 16 Week
Secondary outcomes (1)
FRAIL
The questionnaire aims at fatigue, resistance, ambulation, illness and loss of weight. It is a self reported questionnaire. The sensitivity of FRAIL is 85.8% and a specificity of 80.6%.
The test will be measured at baseline, week 8 and 16
Measured: 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Aug 2023
- Primary completion31 Dec 2023
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985616
- Sponsor's protocol ID
- REC01549 Shanza Nisar
- Status last verified
- Mar 2024
- First submitted
- 3 Aug 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kemmler W, Kohl M, Frohlich M, Jakob F, Engelke K, von Stengel S, Schoene D. Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). J Bone Miner Res. 2020 Sep;35(9):1634-1644. doi: 10.1002/jbmr.4027. Epub 2020 Apr 28.
PubMed 32270891Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26.
PubMed 24864078Abdul-Hameed U, Rangra P, Shareef MY, Hussain ME. Reliability of 1-repetition maximum estimation for upper and lower body muscular strength measurement in untrained middle aged type 2 diabetic patients. Asian J Sports Med. 2012 Dec;3(4):267-73. doi: 10.5812/asjsm.34549.
PubMed 23342225
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Resistance Training on Physical Function in Possible Sarcopenia Cases
- ClinicalTrials.gov ID
- NCT05985616
- Acronym / sponsor ID
- REC01549 Shanza Nisar
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 14 Aug 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.
Studies conducted so far added the dietary supplements along with resistance training as an intervention, we could not determine whether the observed effects of the intervention were due to the training program and/or dietary supplements.
Detailed description
This study will investigate the effects of high intensity resistance training solely in the possible sarcopenia cases which has not done before, to author's knowledge. Furthermore this study will help clinicians to individualize and optimize the therapy for specific patient subgroups, improve the potential of this therapy to improve human function and well being, facilitate timely interventions in community healthcare and prevention settings, which will contribute to higher awareness of sarcopenia prevention and interventions in diverse health care settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: High Intensity Resistance TrainingHigh intensity (80-85% of 1RM) will be administered at alternative days for 16 weeks. The exercise will have three phases; Phase I consists of 2-3 sets of 8-15 repetitions, Phase II will follow the single set approach and Phase III will have the Superset approach. The following activities will be incorporated via resistance training: latissimus front pulleys, rowing, back extension, inverse fly, bench press, shoulder press, lateral raises, butterfly with extended arms, crunches, leg presses, leg extension and curls, leg adduction, abduction. |
| Group B | No intervention | –No intervention will be provided in this group. The participants in this group will follow their usual daily activities. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both male and female
- Age more than 60 years
- Possible sarcopenia cases as defined by Asian Working Group for Sarcopenia (Handgrip strength: Male less than 26kg and Female less than 18kg, 5 time chair stand test more than/equals to 12 seconds)
Key exclusion criteria (7 listed)
- Orthopedic surgery in last one year
- Neurological disorders like stroke etc
- History of recent fractures
- Metabolic disorders like DM etc
- Actively involved in exercise programs
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 |
|---|---|---|
| High Intensity Resistance TrainingHigh intensity resistance training will be performed 3 times a day for sixteen weeks | Other | Group A |
Primary outcome
Hand Dynamometer
Time frame: 16 weeks
it used to measure the hand grip strength. the test-retest reliability is 0.91 and 0.95 with excellent reliability. The assessment will be made at baseline, week 8 and 16
Short performance physical battery
Time frame: 16 Week
an objective assessment tool for evaluating lower extremity functioning in older persons. the test-retest reliability is 0.87. It was used to measure at baseline, week 8 and 16
1 secondary outcome
FRAIL
Time frame: 16 week
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 5 Mar 2024.
- Background: PubMed 32270891Kemmler W, Kohl M, Frohlich M, Jakob F, Engelke K, von Stengel S, Schoene D. Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). J Bone Miner Res. 2020 Sep;35(9):1634-1644. doi: 10.1002/jbmr.4027. Epub 2020 Apr 28.
- Background: PubMed 24864078Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26.
- Background: PubMed 23342225Abdul-Hameed U, Rangra P, Shareef MY, Hussain ME. Reliability of 1-repetition maximum estimation for upper and lower body muscular strength measurement in untrained middle aged type 2 diabetic patients. Asian J Sports Med. 2012 Dec;3(4):267-73. doi: 10.5812/asjsm.34549.
- 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.
Mirza Obaid Baig, MSPT principal investigator
Riphah International 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 High Intensity Resistance Training in people with Sarcopenia, run by Riphah International University at 1 site in Pakistan.
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 7 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 5 Mar 2024. 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 Pakistan. 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?
Hand Dynamometer (time frame: 16 weeks). The study lists 2 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 NCT05985616, which also lists 3 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 5 Mar 2024.