Trial Outcomes & Findings for Effects of Multi-component Exercise on Physical Performance and Sleep Quality in Older Adults (NCT NCT07598123)
NCT ID: NCT07598123
Last Updated: 2026-08-10
Results Overview
Time required to walk 4 meters at usual pace. Gait speed is expressed in meters per second (m/s).
COMPLETED
NA
80 participants
Baseline and week 8
2026-08-10
Participant Flow
Participants were recruited from four community care sites near a university-affiliated senior fitness club in central Taiwan between May 2024 and December 2024. Recruitment announcements and study briefings were conducted on-site. Eligible participants were community-dwelling older adults aged 65 to 90 years who regularly attended health promotion activities at these community care sites. The two community care sites that first reached recruitment targets were assigned to the intervention group
Four community care sites were allocated to study arms. Two sites were assigned to the multi-component group exercise program and two sites were assigned to routine community activities. All eligible participants within each site received the intervention assigned to their site.
Unit of analysis: Community care site
Participant milestones
| Measure |
Multi-component Group Exercise Program
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
baseline
STARTED
|
40 2
|
40 2
|
|
baseline
COMPLETED
|
40 2
|
40 2
|
|
baseline
NOT COMPLETED
|
0 0
|
0 0
|
|
post-test
STARTED
|
40 2
|
40 2
|
|
post-test
COMPLETED
|
36 2
|
39 2
|
|
post-test
NOT COMPLETED
|
4 0
|
1 0
|
Reasons for withdrawal
| Measure |
Multi-component Group Exercise Program
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
post-test
Lost to Follow-up
|
2
|
0
|
|
post-test
Personal reasons
|
2
|
1
|
Baseline Characteristics
The analysis population included all participants who completed baseline assessments.
Baseline characteristics by cohort
| Measure |
an 8-week Multi-component Group Exercise Program
n=40 Participants
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, and cool-down activities. Exercise intensity was monitored using heart rate and perceived exertion.
|
Routine Community Activities
n=40 Participants
Control Group: Participants continued their routine community activities without participating in the structured exercise intervention.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77 years
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
78 years
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
78 years
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Sex: Female, Male
Female
|
31 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
35 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
66 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Sex: Female, Male
Male
|
9 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
5 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
14 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
40 Participants
n=40 Participants • Region of enrollment was assessed for all enrolled participants at baseline.
|
40 Participants
n=40 Participants • Region of enrollment was assessed for all enrolled participants at baseline.
|
80 Participants
n=80 Participants • Region of enrollment was assessed for all enrolled participants at baseline.
|
|
Marital status
having a spouse/partner
|
39 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
38 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
77 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Marital status
not having a spouse/partner
|
1 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
2 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
3 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Residence
Living alone
|
36 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
33 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
69 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Residence
Living with spouse/children
|
4 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
7 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
11 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Chronic disease history
No chronic diseases
|
4 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
2 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
6 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Chronic disease history
One chronic disease
|
12 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
15 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
27 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Chronic disease history
Two chronic diseases
|
12 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
13 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
25 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Chronic disease history
Three or more chronic diseases
|
12 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
10 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
22 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Perceived health status
Very dissatisfied
|
1 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
3 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
4 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Perceived health status
Dissatisfied
|
23 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
17 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
40 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Perceived health status
Satisfied
|
15 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
18 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
33 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Perceived health status
Very Satisfied
|
1 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
2 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
3 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Education level
Primary school and below
|
17 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
22 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
39 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Education level
Junior school
|
7 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
8 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
15 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
|
Education level
High School and above
|
16 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
10 Participants
n=40 Participants • The analysis population included all participants who completed baseline assessments.
|
26 Participants
n=80 Participants • The analysis population included all participants who completed baseline assessments.
|
PRIMARY outcome
Timeframe: Baseline and week 8Population: This analysis utilized an intention-to-treat (ITT) approach including all participants who were randomized into the groups (40 in the intervention group and 40 in the control group). For participants who were lost to post-test or dropped out before the pre-test assessment (4 in the intervention group and 1 in the control group), their missing post-test data were imputed using the last observation carried forward (LOCF) method to ensure the integrity of the two groups.
Time required to walk 4 meters at usual pace. Gait speed is expressed in meters per second (m/s).
Outcome measures
| Measure |
Multi-component Group Exercise Program
n=40 Participants
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
n=40 Participants
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
Time to Walk 4 Meters
week 8
|
3.91 second
Interval 2.21 to 11.6
|
4.07 second
Interval 3.08 to 12.0
|
|
Time to Walk 4 Meters
baseline
|
3.39 second
Interval 2.16 to 13.6
|
4.06 second
Interval 3.0 to 10.9
|
PRIMARY outcome
Timeframe: Baseline and week 8Population: This analysis utilized an intention-to-treat (ITT) approach including all participants who were randomized into the groups (40 in the intervention group and 40 in the control group). For participants who were lost to post-test or dropped out before the pre-test assessment (4 in the intervention group and 1 in the control group), their missing post-test data were imputed using the last observation carried forward (LOCF) method to ensure the integrity of the two groups.
The Chair Stand Test assesses lower-body muscle strength by measuring the time required for participants to complete five chair stands consecutively with arms crossed over the chest.
Outcome measures
| Measure |
Multi-component Group Exercise Program
n=40 Participants
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
n=40 Participants
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
Chair Stand Test
baseline
|
8.4 second
Interval 4.0 to 20.0
|
8.51 second
Interval 5.11 to 17.53
|
|
Chair Stand Test
week 8
|
9.43 second
Interval 5.83 to 17.4
|
9.36 second
Interval 5.1 to 17.7
|
PRIMARY outcome
Timeframe: baseline and week 8Population: This analysis utilized an intention-to-treat (ITT) approach including all participants who were randomized into the groups (40 in the intervention group and 40 in the control group). For participants who were lost to post-test or dropped out before the pre-test assessment (4 in the intervention group and 1 in the control group), their missing post-test data were imputed using the last observation carried forward (LOCF) method to ensure the integrity of the two groups.
The 30-second Arm Curl Test assesses upper-body muscle endurance by counting the number of arm curls completed within 30 seconds using a dumbbell weighing 2.27 kg for women and 3.63 kg for men.
Outcome measures
| Measure |
Multi-component Group Exercise Program
n=40 Participants
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
n=40 Participants
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
30-second Arm Curl Test
baseline
|
23 repetitions
Interval 13.0 to 32.0
|
21 repetitions
Interval 10.0 to 28.0
|
|
30-second Arm Curl Test
week 8
|
25 repetitions
Interval 12.0 to 44.0
|
21 repetitions
Interval 11.0 to 28.0
|
PRIMARY outcome
Timeframe: baseline and week 8Population: This analysis utilized an intention-to-treat (ITT) approach including all participants who were randomized into the groups (40 in the intervention group and 40 in the control group). For participants who were lost to post-test or dropped out before the pre-test assessment (4 in the intervention group and 1 in the control group), their missing post-test data were imputed using the last observation carried forward (LOCF) method to ensure the integrity of the two groups.
The Grip Strength Test assesses hand muscle strength using a hand dynamometer. Participants perform maximal grip force with the dominant hand, and the measured force is recorded in kilograms.
Outcome measures
| Measure |
Multi-component Group Exercise Program
n=40 Participants
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
n=40 Participants
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
Grip Strength Test
baseline
|
23 kg
Interval 14.0 to 41.0
|
22 kg
Interval 12.0 to 42.0
|
|
Grip Strength Test
week 8
|
26 kg
Interval 14.0 to 45.0
|
24 kg
Interval 16.0 to 40.0
|
PRIMARY outcome
Timeframe: baseline and week 8Population: This analysis utilized an intention-to-treat (ITT) approach including all participants who were randomized into the groups (40 in the intervention group and 40 in the control group). For participants who were lost to post-test or dropped out before the pre-test assessment (4 in the intervention group and 1 in the control group), their missing post-test data were imputed using the last observation carried forward (LOCF) method to ensure the integrity of the two groups.
The Side-by-Side Stand Test assesses static balance by measuring the participant's ability to maintain a side-by-side standing position without assistance.
Outcome measures
| Measure |
Multi-component Group Exercise Program
n=40 Participants
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
n=40 Participants
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
Side-by-Side Stand Test
baseline
|
10 second
Interval 10.0 to 10.0
|
10 second
Interval 10.0 to 10.0
|
|
Side-by-Side Stand Test
week 8
|
10 second
Interval 6.0 to 10.0
|
10 second
Interval 10.0 to 10.0
|
PRIMARY outcome
Timeframe: baseline and week 8Population: This analysis utilized an intention-to-treat (ITT) approach including all participants who were randomized into the groups (40 in the intervention group and 40 in the control group). For participants who were lost to post-test or dropped out before the pre-test assessment (4 in the intervention group and 1 in the control group), their missing post-test data were imputed using the last observation carried forward (LOCF) method to ensure the integrity of the two groups.
The Tandem Stand Test assesses static balance by measuring the length of time participants can maintain a heel-to-toe standing position, up to a maximum of 10 seconds.
Outcome measures
| Measure |
Multi-component Group Exercise Program
n=40 Participants
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
n=40 Participants
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
Tandem Stand Test
baseline
|
10 second
Interval 10.0 to 10.0
|
10 second
Interval 10.0 to 10.0
|
|
Tandem Stand Test
week 8
|
6 second
Interval 0.0 to 12.0
|
7 second
Interval 4.0 to 14.0
|
PRIMARY outcome
Timeframe: baseline and week 8Population: This analysis utilized an intention-to-treat (ITT) approach including all participants who were randomized into the groups (40 in the intervention group and 40 in the control group). For participants who were lost to post-test or dropped out before the pre-test assessment (4 in the intervention group and 1 in the control group), their missing post-test data were imputed using the last observation carried forward (LOCF) method to ensure the integrity of the two groups.
The 2.44-meter Timed Walk Test assesses mobility and dynamic balance by recording the time required for participants to stand up from a seated position, walk 2.44 meters around a cone, and return to the chair.
Outcome measures
| Measure |
Multi-component Group Exercise Program
n=40 Participants
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
n=40 Participants
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
2.44-meter Timed Walk Test
baseline
|
6.7 second
Interval 4.45 to 17.3
|
7.12 second
Interval 4.31 to 20.0
|
|
2.44-meter Timed Walk Test
week 8
|
7.11 second
Interval 4.91 to 17.84
|
7.77 second
Interval 4.0 to 30.0
|
PRIMARY outcome
Timeframe: Baseline and week 8Population: This analysis utilized an intention-to-treat (ITT) approach including all participants who were randomized into the groups (40 in the intervention group and 40 in the control group). For participants who were lost to post-test or dropped out before the pre-test assessment (4 in the intervention group and 1 in the control group), their missing post-test data were imputed using the last observation carried forward (LOCF) method to ensure the integrity of the two groups.
Sleep quality was assessed with the Chinese version of Pittsburgh Sleep Quality Index (CPSQI), a validated translation of the Pittsburgh Sleep Quality Index (PSQI). It includes nine self-reported items scored across seven domains: subjective sleep quality, latency, duration, habitual efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction, all assessed over the past month. Scores range from 0 to 21, with scores greater than 5 indicating poor sleep quality.
Outcome measures
| Measure |
Multi-component Group Exercise Program
n=40 Participants
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
n=40 Participants
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
Sleep Quality
week 8
|
6 points
Interval 0.0 to 12.0
|
7 points
Interval 4.0 to 14.0
|
|
Sleep Quality
baseline
|
8 points
Interval 3.0 to 12.0
|
7 points
Interval 4.0 to 14.0
|
SECONDARY outcome
Timeframe: Week 1 and Week 8Population: This analysis utilized an intention-to-treat (ITT) approach including all participants who were randomized into the groups (40 in the intervention group and 40 in the control group). For participants who were lost to post-test or dropped out before the pre-test assessment (4 in the intervention group and 1 in the control group), their missing post-test data were imputed using the last observation carried forward (LOCF) method to ensure the integrity of the two groups.
Heart rate recovery (HRR) was assessed two minutes after treadmill exercise and defined as the difference between heart rate immediately post-exercise and at two minutes recovery.
Outcome measures
| Measure |
Multi-component Group Exercise Program
n=40 Participants
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, balance training, flexibility exercises, and cool-down activities.
|
Routine Community Activities
Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
Heart Rate Recovery
Week 1
|
14 beats per minute
Interval 3.0 to 36.0
|
—
|
|
Heart Rate Recovery
week 8
|
17.5 beats per minute
Interval 2.0 to 39.0
|
—
|
Adverse Events
an 8-week Multi-component Group Exercise Program
Routine Community Activities
Serious adverse events
| Measure |
an 8-week Multi-component Group Exercise Program
n=40 participants at risk
Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, and cool-down activities. Exercise intensity was monitored using heart rate and perceived exertion.
|
Routine Community Activities
n=40 participants at risk
Control Group: Participants continued their routine community activities without participating in the structured exercise intervention.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
hospitalization
|
2.5%
1/40 • Number of events 1 • from enrollment until end of post test, up to 8 weeks
Adverse events (AEs) were monitored at each study visit and through participant self-report. AEs included headache, dizziness, respiratory discomfort, falls with abrasions, hypoglycemia, and other medical events reported during the study. Serious adverse events (SAEs) included falls requiring hospitalization, hospitalization for any cause, persistent or significant disability, life-threatening events, or death. All AEs and SAEs were documented and summarized for analysis.
|
2.5%
1/40 • Number of events 1 • from enrollment until end of post test, up to 8 weeks
Adverse events (AEs) were monitored at each study visit and through participant self-report. AEs included headache, dizziness, respiratory discomfort, falls with abrasions, hypoglycemia, and other medical events reported during the study. Serious adverse events (SAEs) included falls requiring hospitalization, hospitalization for any cause, persistent or significant disability, life-threatening events, or death. All AEs and SAEs were documented and summarized for analysis.
|
|
Eye disorders
Surgical hospitalization
|
2.5%
1/40 • Number of events 1 • from enrollment until end of post test, up to 8 weeks
Adverse events (AEs) were monitored at each study visit and through participant self-report. AEs included headache, dizziness, respiratory discomfort, falls with abrasions, hypoglycemia, and other medical events reported during the study. Serious adverse events (SAEs) included falls requiring hospitalization, hospitalization for any cause, persistent or significant disability, life-threatening events, or death. All AEs and SAEs were documented and summarized for analysis.
|
0.00%
0/40 • from enrollment until end of post test, up to 8 weeks
Adverse events (AEs) were monitored at each study visit and through participant self-report. AEs included headache, dizziness, respiratory discomfort, falls with abrasions, hypoglycemia, and other medical events reported during the study. Serious adverse events (SAEs) included falls requiring hospitalization, hospitalization for any cause, persistent or significant disability, life-threatening events, or death. All AEs and SAEs were documented and summarized for analysis.
|
Other adverse events
Adverse event data not reported
Additional Information
Yi-Ling Tseng/Principal Investigator
Tunghai University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place