NCT05985616

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

August 3, 2023

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    16 Week

Secondary Outcomes (1)

  • FRAIL

    16 week

Study Arms (2)

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.

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.

Interventions

High intensity resistance training will be performed 3 times a day for sixteen weeks

Group A

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbas Institute of Medical Sciences

Muzaffarabad, Azad Kashmir, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 32270891BACKGROUND
  • Singh 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.

    PMID: 24864078BACKGROUND
  • Abdul-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.

    PMID: 23342225BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Mirza Obaid Baig, MSPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

August 15, 2023

Primary Completion

December 31, 2023

Study Completion

January 19, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations